[Federal Register Volume 71, Number 243 (Tuesday, December 19, 2006)]
[Rules and Regulations]
[Pages 75865-75879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21591]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. 2003N-0056 (formerly 03N-0056)]


Medical Devices; Patient Examination and Surgeons' Gloves; Test 
Procedures and Acceptance Criteria

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to improve the barrier quality of medical gloves marketed in the United 
States. The rule will accomplish this by reducing the current 
acceptable quality levels (AQLs) for leaks and visual defects observed 
during FDA testing of medical gloves. By reducing the AQLs for medical 
gloves, FDA will also harmonize its AQLs with consensus standards 
developed by the International Organization for Standardization (ISO) 
and ASTM International (ASTM).

DATES: This rule is effective December 19, 2008.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of 
Compliance, Center for Devices and Radiological Health (HFZ-300), Food 
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0100.

SUPPLEMENTARY INFORMATION:

I. Background

    Since 1990, FDA has tested patient examination and surgeons' gloves 
for barrier integrity in accordance with the sampling plans, test 
method, and AQLs contained in Sec.  800.20 (21 CFR 800.20). The FDA 
test method was adopted by the consensus standards organizations, ISO 
and ASTM, who incorporated this method in ISO 10282, ISO 11193, ASTM 
D3577, and ASTM D 3578. Subsequently, ISO and ASTM lowered

[[Page 75866]]

the AQLs in their consensus standards to be more stringent than the 
criteria in the FDA test method. In the Federal Register dated March 
31, 2003 (68 FR 15404), FDA published a proposed rule to amend the FDA 
test method and harmonize the acceptance criteria with those in the 
consensus standards. We provided a period of 90 days for comments from 
interested parties. We received comments from several parties, which we 
summarize and discuss below, and we have revised the final rule in 
response to the comments as appropriate.
    (Comment 1) FDA received several comments expressing concern that 
the proposal to lower the AQLs in the FDA rule to match those in the 
ASTM standard does not truly harmonize with ASTM because ASTM applies 
the AQLs only to pinhole defects, whereas FDA applies the AQLs to both 
pinhole and visual defects.
    Historically, FDA has always considered visual defects that affect 
barrier integrity as failures during glove testing. The visual analysis 
of gloves while conducting water leak testing was specifically included 
in the original FDA test method published in December 1990 and codified 
at Sec.  800.20. Our experience with laboratory analyses of medical 
gloves indicates that visual defects are relatively rare. However, due 
to public health concerns, FDA cannot ignore visual defects when they 
are observed. FDA will continue to consider visual defects affecting 
barrier integrity as failures. FDA does not agree that including these 
defects in the analysis will affect harmonization with currently 
recognized consensus standards for the vast majority of samples.
    FDA has, however, included language in the rule clarifying that 
only visual defects that are likely to affect the barrier integrity 
should be counted as failures and has described the main types of 
visual defects that are likely to affect barrier integrity. FDA 
understands the concerns of manufacturers that the lower AQLs could 
result in more sample failures, especially if FDA analysts count visual 
defects that do not affect barrier integrity. Therefore, FDA intends to 
provide guidance to analysts on how to identify visual defects that 
affect barrier integrity.
    (Comment 2) One comment disagreed with the FDA statement ``Because 
the standards organization updated their standards to reflect the 
improvement in manufacturing technology, the consensus standards 
currently have lower AQLs for medical gloves than FDA's regulations'' 
on the grounds that the consensus standards' AQLs do not count visual 
defects. The commenter proposed that FDA reword this statement.
    Until now, the AQLs in the consensus standards have been tighter 
than those in the FDA test method, even when visual defects are 
considered. As noted previously, visual defects are rarely observed. 
Even when they are found, they may not increase the total number of 
failures in an analysis because the tears and holes detected by means 
of a visual examination would most likely leak if subjected to water 
leak testing and count as failures. Other visually defective gloves, 
such as adhering gloves, which often tear when pulled apart, might also 
leak if subjected to water leak testing.
    (Comment 3) FDA received a number of comments expressing concern 
that the phrase ``other defects visible upon initial examination that 
may affect the barrier integrity'' is subject to interpretation. Some 
comments recommended a list of specific criteria for identifying 
visually defective gloves. Other comments suggested adding the word 
``obvious'' before ``defects.''
    FDA understands these concerns and has revised the rule to include 
more examples of specific visual defects that should be considered as 
failures. However, FDA realizes that it cannot predict all possible 
defects that may be encountered. Therefore, the phrase immediately 
following the list of specifically identified visual defects has been 
revised to read, ``or other visual defects that are likely to affect 
the barrier integrity.'' FDA disagrees that adding ``obvious'' before 
``defects'' would clarify the type of defects that should be counted or 
reduce the risk of subjective interpretation.
    (Comment 4) FDA received several comments requesting us to revise 
the test procedure and acceptance criteria to have two sets of samples 
per lot, one set for testing for pinhole defects and the second set for 
testing or determining visual defects. The comments suggested that 
visual defects should have less stringent AQLs than pinhole defects. 
Also, one comment stated that the test certificates glove manufacturers 
routinely issue generally categorize pinholes and visual defects 
separately.
    FDA disagrees with these comments. FDA is aware that glove 
manufacturers routinely inspect their gloves for visual cosmetic 
defects that may affect the acceptability of the gloves to buyers. 
Since these defects are related to the cosmetic appearance of gloves 
rather than safety, they are visually inspected at a lower AQL than 
pinhole defects. In contrast, FDA analysis of medical gloves is 
intended to ensure that gloves are safe and effective for their 
intended use, barrier protection. The FDA test method includes only 
those visual defects, such as tears, embedded foreign objects, etc., 
that are likely to affect the barrier integrity of the glove. As 
previously stated, FDA has historically considered visual defects that 
affect the barrier integrity as failures during glove testing and has 
always included them in the total count of defective gloves. Sampling 
and counting visual defects that affect barrier integrity separately 
from gloves that leak during the water leak test would change 
established FDA sampling procedures and could allow more total defects 
in glove lots than were allowed under the previous AQLs. This would not 
be consistent with the purpose of this rulemaking to improve the 
quality of gloves on the U.S. market. Also, because visual defects that 
affect barrier integrity are much less common than cosmetic visual 
defects, they would probably not be present in the majority of samples. 
Routinely taking two sets of samples when one sample is expected to 
have no defects would be an inefficient use of resources for the FDA. 
The increased time required for two analyses could also result in 
delaying entry of imported products.
    (Comment 5) Three comments noted that the ASTM standards for 
patient examination and surgeons' gloves specify the use of single 
normal sampling plans rather than the multiple normal sampling plans 
used by FDA.
    FDA understands that ASTM uses single normal sampling. However, the 
same ISO document that ASTM references for its single sampling plans 
(ISO 2859, ``Sampling Procedures for Inspection by Attributes'') also 
provides multiple sampling plans that establish the acceptability or 
non-acceptability of the lot with equivalent statistical confidence, 
but generally using a much smaller total sample size. In view of the 
volume of gloves that FDA must test each year, we cannot justify the 
additional expense that would accompany the use of the single sampling 
plans. Since the sampling plans are statistically very similar, we 
consider the revised test method and acceptance criteria to be 
harmonized with the ASTM standard.
    (Comment 6) Another comment stated that it was unlikely that 
manufacturers could supply medical gloves that meet the new AQLs 
without any price increase. The comment further stated that tightening 
the AQLs would cause manufacturers to test to even tighter in-house 
specifications, which could lead to significant ``downgrading'' of some 
lots of gloves.
    It is FDA's understanding, based on representations made in 510(k)

[[Page 75867]]

submissions and interactions with glove manufacturers, that the glove 
industry is already manufacturing gloves that meet the 1.5 and 2.5 AQLs 
for surgeons' and patient examination gloves, respectively. FDA 
recognizes that some manufacturers may decide to withhold from the 
market or ``downgrade'' some glove lots in order to reduce the risk of 
failing the FDA test. However, our analysis, described in section III.E 
of this document, indicates that the actual number of lots that would 
have to be withheld in order to maintain the current failure risk level 
is a small percentage of the total number of gloves manufactured and, 
consequently, will have a minimal impact on the industry.
    (Comment 7) We received several comments that pointed out that an 
AQL value should not reference a percentage because it is technically a 
number without a unit. The comments suggested that we remove the 
reference to percent.
    FDA agrees with this comment. The AQL values in the final rule do 
not refer to percent.
    (Comment 8) One comment requested that the effective date of this 
rule be delayed until the year 2010.
    FDA disagrees with this comment. ASTM lowered its AQLs for 
surgeons' and patient examination gloves in 1998. FDA believes that 
manufacturers have had sufficient time to adapt their manufacturing 
process to conform to these standards and that, in fact, the vast 
majority of currently manufactured gloves already meet the new AQLs.
    (Comment 9) One comment suggested the use of normal sampling plans 
in ISO 2859 for reconditioned lots instead of the tightened sampling 
plans proposed by FDA. This comment maintained that the normal 
inspection plans were the optimal plans for glove lots and that these 
same sampling plans should also be used for reconditioned lots for both 
technical and economic reasons.
    FDA disagrees with this comment. When testing reconditioned lots, 
FDA needs greater assurance that the gloves are safe and effective 
because there has already been an initial failure and an appearance of 
adulteration. It is important, therefore, that the tightened sampling 
plans be used to test reconditioned lots.
    (Comment 10) One comment advised that the sampling plan for 
Surgeons' Gloves at 1.5 AQL Normal Sampling and a lot size of 1,201 to 
3,200 does not provide for lot acceptance for the first 32 gloves 
sampled.
    FDA agrees and has revised the chart.
    (Comment 11) One comment asked why the tables for both the 
Surgeons' and Patients Examination Gloves were changed from the 
original rule to list increasing quantities of gloves from top to 
bottom rather than from bottom to top.
    This change was made to harmonize with the tables in the ISO-2859 
sampling plans.
    (Comment 12) One comment noted that the leak test materials and set 
up described in Sec.  800.20 are an example of what might be used in 
small scale testing environments, but that the use of these materials 
and set up in high volume test environments is not realistic. Another 
comment pointed out that many manufacturers use opaque cylinders rather 
than clear plastic cylinders, as described in paragraph Sec.  
800.20(b)(2)(i). A suggestion was made to note that the materials and 
set up described in Sec.  800.20(b)(2) and (b)(3)(ii) are only 
examples.
    FDA agrees that the materials and set up described in the 
referenced section are only examples and may not be realistic for high 
volume test settings and, therefore, has changed the wording in Sec.  
800.20(b)(2) Leak test materials, to ``FDA considers the following to 
be the minimal materials required for this test.'' FDA will continue to 
use clear cylinders to remain harmonized with the ASTM consensus 
standard D5151 for detection of holes in medical gloves.
    (Comment 13) One comment recommended that FDA define the elongation 
and tensile strength required for medical grade gloves.
    This comment is beyond the scope of this rule. This rule describes 
a barrier test method applicable to gloves of all materials and not a 
physical properties test method that will necessarily vary for 
differing materials.
    (Comment 14) A suggestion was made to increase the water leak test 
duration to 3 minutes from the current 2 minutes because there are some 
gloves that begin to leak shortly after the 2 minute mark, usually at 2 
minutes and 30 seconds.
    Changes to this rule are intended to harmonize with the current 
consensus standards. Harmonization would not be accomplished if FDA 
were to increase its water leak test duration to 3 minutes. Moreover, 
there are no reliable data justifying the increase.
    (Comment 15) One comment suggested that Sec.  800.20(b)(2)(iv) 
should be moved to the preamble because it is a guidance.
    It is important that FDA's test method for analyzing gloves be 
presented in a coherent manner that thoroughly describes the method in 
a way that is understandable. FDA believes that deleting Sec.  
800.20(b)(2)(iv) from the codified language would make the test method 
more difficult to understand and, therefore, disagrees that it should 
be moved to the preamble.
    (Comment 16) A suggestion was made to move ``Record the number of 
defective gloves'' from (b)(3)(iii)(B) to a new paragraph 
(b)(3)(iii)(C). The rationale for this suggestion was that the data are 
generated in both (b)(3)(iii)(A) and (b)(3)(iii)(B), and not in just 
(b)(3)(iii)(B). Therefore, it appeared that the recording requirement 
should be in a separate paragraph.
    FDA agrees and has removed ``Record the number of defective 
gloves'' from section (b)(3) (iii)(B) and added a new section 
``(b)(3)(iii)(C), Record the number of defective gloves.''
    (Comment 17) Another comment stated that the preamble should 
discuss the relationship between Import Alert 80-04 and Sec.  800.20.
    This rule describes FDA's analytical test method for determining 
whether individual gloves are defective and acceptance criteria for 
determining whether lots of medical gloves are adulterated. It applies 
equally to medical gloves offered for import and medical gloves already 
in domestic distribution. While the results of analysis could cause a 
firm to be placed on Import Alert 80-04, this rule is not intended to 
describe or modify FDA's current guidance to FDA field personnel 
regarding ``Surveillance and Detention Without Physical Examination of 
Surgeon's and or Patient Examination Gloves,'' which is contained in 
Import Alert 80-04.
    (Comment 18) One comment suggested that we add the following or 
equivalent language to (d)(2)(ii) ``Adulteration levels and acceptance 
criteria for reconditioned gloves'': ``FDA considers the reconditioned 
lot of medical gloves tested by an independent laboratory under 
tightened sampling to meet the AQLs which will provide additional 
assurance to the consumers. If the retest result has been determined to 
be acceptable, the initial analysis of the failed lot before 
reconditioning shall be nullified.''
    FDA disagrees with this comment. When a collection of gloves that 
has been seized or refused entry based on a violative sample is 
``reconditioned,'' some of the problematic sizes or lots of the gloves 
may have been removed (segregated) from the reconditioned sample. When 
this occurs, and the reconditioned sample passes the test under the 
tightened sampling plan, FDA will consider the remaining/reconditioned 
lots in the collection of gloves to be acceptable, as described in 
Sec.  800.20. However, FDA believes that, in the situation described 
previously, FDA

[[Page 75868]]

cannot ignore the initial failure which is part of the firm's 
historical record.
    (Comment 19) Several comments mentioned that the rule would result 
in increased costs to consumers of gloves. These comments asserted that 
manufacturing and production changes at manufacturing sites would 
entail significant costs that would ultimately be passed on to 
consumers in the form of price increases.
    FDA disagrees with these comments. As stated in section III of this 
document, most lots of imported gloves already meet the lower AQLs. 
This implies that significant changes in the manufacturing processes 
will not be necessary. In addition, there is no universal economic 
presumption that costs are passed on to consumers in order to maintain 
a constant profit margin to manufacturers. Market conditions will 
dictate the specific degree to which regulatory costs are borne by 
various economic sectors, i.e., manufacturers, distributors, 
purchasers, payers, or consumers. Because of the competitive nature of 
this industry and the relatively small proportion of gloves affected by 
this rule, FDA believes that these costs are not likely to be directly 
passed on in the form of price increases.

II. Environmental Impact

    The agency has determined under 21 CFR 25.30(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

A. Introduction

    FDA has examined the final rule under Executive Order 12866, the 
Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). FDA has determined that 
this final rule is not a significant regulatory action under the 
Executive order.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize the impact of the rule 
on small entities. Because this final rule will not result in economic 
impacts on domestic small entities, the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act requires that 
agencies prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing a final rule that 
includes any Federal mandate that may result in the expenditure of 
State, local and tribal governments, in the aggregate, or the private 
sector of $100 million or more (adjusted annually for inflation) in any 
one year. The current threshold after adjustment for inflation is $118 
million, using the most current (2004) implicit price deflator for the 
Gross National Product. The agency does not expect this final rule to 
result in a 1-year expenditure that would meet or exceed this amount.
    The information in the following sections sets forth the bases for 
the above conclusions. We show the expected annual costs and benefits 
of this final rule next in Table 1. The average annualized costs of the 
final rule are estimated to be $6.6 million using either a 3 percent or 
7 percent discount rate. Average annualized benefits are expected to be 
between $14.8 million and $15.1 million, depending on the discount 
rate. Average annualized net benefits are between $8.2 million and $8.5 
million.

                        Table 1.--Average Annualized Costs and Benefits (in millions)\1\
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                  Annual Discount Rate                         Costs             Benefits         Net Benefits
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3 Percent                                                             $6.6              $14.8               $8.2
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7 Percent                                                             $6.6              $15.1               $8.5
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\1\Annualized over a 10-year evaluation period.

B. Objective of the Final Rule

    The objective of the final rule is to reduce the risk of 
transmission of blood-borne pathogens (particularly human 
immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) 
infections). The rule accomplishes this objective by ensuring that 
medical gloves (surgeons' and patient examination gloves) maintain a 
high level of quality with respect to the level of noted defects. FDA 
is also harmonizing its level for acceptable defects with consensus 
quality standards developed by ISO and ASTM.

C. Current Risks of Blood-Borne Illness

    Unnecessary exposures to blood-borne pathogens are of great 
importance to the health care community because contact with 
contaminated human blood or tissue products has led to increased cases 
of HIV, HBV, and HCV infections.
    Available data cannot precisely quantify the number of new HIV 
cases that this final rule will prevent. This analysis, however, 
attempts to derive a conservative estimate. For the year 2000, the 
Centers for Disease Control (CDC) reported a cumulative total of 
approximately 900,000 persons in the United States who had contracted 
HIV, of which 775,000 cases had progressed to Acquired Immunodeficiency 
Syndrome (AIDS) (Ref. 1). Of those patients whose conditions had 
progressed to AIDS, almost 450,000 (58 percent) had died as of December 
2000. For the year 2000, the CDC identified 21,704 new cases of HIV 
infection.
    Approximately 5 percent of the reported HIV/AIDS cases were among 
health care personnel (Ref. 2). However, in an indepth analysis of 
occupational risk, the CDC reported that between 1992 and 2002 there 
had been 56 identified incidents of occupational transmission of the 
HIV pathogen and all but 7 of these cases (12.5 percent) were due to 
percutaneous cuts or needlesticks. In addition, there were 138 other 
cases of HIV infection or AIDS among health care workers with 
occupational exposures to blood who had not reported other risk factors 
for HIV infection (Ref. 2). Assuming the same 12.5 percent rate for 
these workers implies that 17 additional cases of HIV transmission to 
health care workers during this period might have been caused by 
cutaneous contact in an occupational setting. Consequently, a total of 
24 incidents of occupational transmission of HIV to health care 
personnel may have occurred over the

[[Page 75869]]

10-year period (or 2.4 per year) due to problems with the barrier 
protection properties of gloves used in health care settings.
    The CDC also reports approximately 80,000 new cases of HBV for the 
latest available reporting period (1999) (Ref. 3). There are 
approximately 1.25 million people in the United States chronically 
infected with HBV. While only 6 percent of those who contract hepatitis 
B after the age of 5 will develop chronic conditions, 15 to 25 percent 
of those that do will die prematurely. Health care personnel are at 
some risk from this pathogen, but the availability of a vaccine has 
reduced the risk of negative outcomes due to exposure.
    FDA has no direct data for estimating the rate of new HBV 
infections in health care personnel. While the CDC has reported the 
risk to health care workers as ``low,'' there is no definition of that 
term (Refs. 3 and 4). FDA estimates that as many as 4,000, or 5 
percent, of all new incidents of HBV occur in health care personnel. 
Because occupational transmissions for HBV may be approximately 5 times 
more likely than that for HIV, FDA imputes approximately 140 annual 
cases of occupational transmission of HBV to health care personnel (HIV 
rate of 7.3/1,085 x 5 x 4,000.) CDC analyses have stated that ``most'' 
of the occupational transmissions are due to percutaneous injuries 
(Ref. 4). Because 2.4 of the 7.3 annual HIV cutaneous contact 
transmissions (33 percent) were believed to be attributable to glove 
defects, FDA similarly expects about one-third of the 140 annual 
occupational transmissions of HBV infections (approximately 40 cases) 
may potentially be associated with the current quality level of medical 
gloves. If only 6 percent of these cases develop chronic conditions, 
then an average of 2.4 annual cases of chronic HBV are associated with 
defective medical gloves.
    HCV currently infects 3.9 million persons in the United States 
(Ref. 3). Over 2.7 million patients have reported chronic conditions. 
More than 40,000 new cases were reported in 1999. The risk of exposure 
to health care workers, however, appears to be extremely low. In fact, 
according to the CDC, other than from needle stick punctures, there has 
been no documented transmission of HCV to health care personnel from 
intact or non-intact skin exposures to blood or other fluids or tissues 
(Ref. 4). Thus, there is little evidence that glove defects are 
associated with HCV exposures.
    As a result, FDA estimates the overall annual transmission of 
blood-borne pathogens due to defects in glove barrier protection in 
health care settings to include 2.4 cases of HIV infection and 2.4 
cases of HBV infection. Increasing the AQL of gloves by lowering the 
rate of acceptable defects should reduce the transmission rates of 
these pathogens.

D. Baseline Conditions

    The previous AQL (being replaced by this rule) for medical gloves 
allowed a defect rate of 4.0 percent for patient examination gloves and 
2.5 percent for surgeons' gloves. The AQL represents the proportion of 
sampled gloves from a given lot that may include defects such as leaks 
or foreign material and still be accepted for entry into the 
marketplace. Currently, if more than 4 percent of the sampled patient 
examination gloves exhibit defects in accordance with the sampling 
criteria, the entire lot of gloves is considered adulterated. Surgeons' 
gloves are sampled to a higher quality level (lower AQL requires a 
higher proportion of non-defective gloves in order to pass inspection), 
because these products have a higher likelihood of contact with bodily 
fluids. Of course, medical glove lots that fail to meet the AQL may be 
marketed as household or other products. If a sample of gloves fails to 
meet the AQL, the marketer may request resampling of the lot. The 
required sampling plan for a lot originally found to be out of 
compliance is more intensive than the original sampling plan for a 
randomly selected lot. Lots initially found to be out of compliance are 
either resampled and subsequently offered as medical devices after 
meeting the current AQL, offered as nonmedical gloves, or sold in 
foreign markets.
    Approximately 39.2 billion medical gloves were imported into the 
United States during 2004 (Ref. 6). According to FDA records, there are 
over 400 manufacturers of medical gloves. Malaysian manufacturers 
supply almost 40 percent of the medical gloves in the United States 
while Chinese manufacturers supply approximately 30 percent (Ref. 7). 
Surgeons' gloves accounted for only about 15 percent of all imported 
medical gloves during 2004, and the impact of the final rule on this 
sector is negligibly different from overall patient examination gloves. 
Therefore, this analysis focuses exclusively on patient examination 
gloves.
    FDA expects the demand for medical gloves to increase by the same 
rate as employment in the medical services industry. The Bureau of 
Labor Statistics has projected annual employment growth of 2.6 percent 
for this industry (North American Industry Classification System 6200) 
(Ref. 8), which implies an annual volume of over 50 billion medical 
gloves in 10 years. (A 2.6 annual growth rate results in an expected 
increase of 29.3 percent in 10 years.)
    Medical glove lot sizes may vary from as few as 25 gloves to as 
many as 500,000. According to discussions with manufacturers (Eastern 
Research Group, Inc. (ERG) 2001), a typical production or import lot 
from a foreign manufacturer contains an average of 325,000 gloves 
(either patient examination or surgeons'). This implies that the U. S. 
medical glove market currently imports over 120,600 lots of gloves per 
year. FDA currently samples only about 1.5 percent of all glove lots, 
or 1,800 lots per year. Within 10 years, FDA expects the number of lots 
offered for import to increase to 156,000. If the compliance sampling 
rate remains constant, FDA would sample about 2,300 lots during that 
year.
    FDA's Winchester Engineering and Analysis Center (WEAC) analyzed 
results from samples collected from 2000 and 2001. These samples 
represent approximately one-third of FDA's total sampling effort for 
the period. A total of 98,067 gloves were tested from 942 separate 
lots. Of these gloves, 2,354 were defective, which implies that 2.4 
percent of marketed gloves are likely to be defective. If so, then 
approximately 940 million defective medical gloves are currently 
marketed (39.2 billion gloves x 0.024). At the current AQL of 4.0, 28 
lots (2.97 percent) failed. Consequently, approximately 53 annually 
sampled lots are defective (1,800 sampled lots x 0.0297). By the 10th 
year, in the absence of the final regulation, 1.21 billion defective 
gloves would be marketed and 68 of the sampled lots would fail to meet 
the AQL.
    FDA allows glove lots that fail to meet the AQL to be resampled. 
Sponsors usually attempt to resample the glove lot rather than divert 
the entire lot to alternative markets. According to discussions with 
industry sources and testing laboratories, the cost of glove lot 
resampling and retesting for leakage and tensile strength is 
approximately $1,400. The current annual industry cost of resampling 
glove lot failures with the current AQL is approximately $74,000 (53 
lots times $1,400 per lot). This resampling and retesting cost would 
equal $95,000 within 10 years.

E. Costs of the Final Rule

    FDA expects that the final rule will result in changed shipping 
practices by medical glove manufacturers. Currently, manufacturers use 
the target AQLs as a guide for releasing production lots of

[[Page 75870]]

gloves for export to the United States because the release criteria are 
lower in the United States than in other markets. Manufacturers attempt 
to avoid having three failures within a 24-month period, because this 
may result in refusal of future imports under Level 3 detention 
described in FDA's current policy, ``Surveillance and Detention Without 
Physical Examination of Surgeon's and/or Patient Examination Gloves.'' 
Thus, to maintain an uninterrupted supply of gloves to customers, and 
to guard brand loyalty while avoiding Level 3 detention, manufacturers 
would be expected to raise their level of quality control to at least 
maintain the current average lot rejection rate of 2.97 percent. FDA 
also expects the rule to increase the costs of sampling by requiring 
larger and more detailed sampling plans to assure the lower AQL is met 
for each inspected glove lot. FDA does not envision increased 
regulatory oversight costs because the rate of inspections is not 
expected to change. Costs have been analyzed and discounted using the 
methodology suggested by OMB's Circular A-4 (September 2003).
1. Costs of Quality Control
    Manufacturers currently conduct quality control tests on glove lots 
prior to release. These tests include water-tight leak and tensile 
strength assays. According to interviews with glove manufacturers, the 
current cost of conducting these tests at the manufacturing site is 
approximately $310 per lot, while the more stringent quality control 
testing required by this rule may cost an additional $45 per lot. The 
additional cost is for increased inventory and larger sample sizes to 
ensure more precise measurements at the lower AQL. Because 
approximately 120,600 lots are currently imported per year, the 
expected costs are $5.4 million (120,600 lots x $45 per lot). The 
expected increase in the demand for medical gloves by the 10th 
evaluation year will result in a compliance cost of meeting this 
increased quality level of $7.0 million. Over the 10-year period, the 
average annualized cost of this increased level of testing, at a 3 
percent annual discount rate, is $6.2 million and, at a 7 percent 
annual discount rate, is $6.2 million.
2. Increased Sampling Costs
    A lower AQL will result in increased sampling costs for imported 
glove lots. The increased sampling costs will result from the need to 
test greater quantities of gloves in order to ensure sufficient 
statistical power. Based on reported costs from U.S. testing 
laboratories, ERG, an independent economic contractor, estimated that 
increased testing would add approximately $200 to the current costs of 
$1,400 per sample. (The difference between this increased cost and the 
$45 increased quality control cost is attributable to lower costs in 
foreign countries that produce medical gloves.) FDA currently samples 
about 1.5 percent of the 120,600 lots imported annually, or 1,800 
samples. Thus, the increased sampling costs due to this final rule are 
$0.4 million (120,600 lots x 0.015 x $200). Within 10 years, this 
increased cost will equal $0.5 million (due to expected increases in 
the number of inspected glove lots). The average annualized sampling 
cost increase at a 3 percent annual discount rate is $0.4 million, and 
at a 7 percent annual discount rate is $0.4 million.
3. Withheld Lots
    The lower AQL in this final rule is also likely to result in an 
increase in the number of lots of medical gloves that are not released 
for shipment to the U.S. medical market. For example, manufacturers may 
attempt to maintain a target compliance level in order to avoid FDA's 
Level 3 detention under ``Surveillance and Detentions Without Physical 
Examination of Surgeon's and or Patient Examination Gloves.'' FDA's 
WEAC laboratory sampled 942 lots and discovered that 28 failed using 
the current AQL while 79 lots failed using the lower AQL in this final 
rule. To maintain the original 0.0297 (28/942) lot failure rate, the 53 
lots with the highest defect rate would have to be held back by the 
affected manufacturers (.056)\1\.
---------------------------------------------------------------------------

    \1\The current lot failure rate (28/942 = 0.0297) is reached by 
removing 53 defective lots from the sample. If only the 51 
additional failing lots are removed, the overall failure rate is 
0.0314 (28/891). The expected future failure rate is 0.0292 (26/
889). FDA expects the withheld lots to include those with the 
highest defect rates.
---------------------------------------------------------------------------

    Therefore, FDA anticipates that under the lower AQL in the final 
rule, approximately 6,900 lots will be held back by manufactures. In 
order to meet the expected demand in 10 years, FDA expects that 9,000 
lots will be held back. FDA believes that glove lots that fail to meet 
the lower AQL in this final rule for medical quality standards will 
most likely be sold as nonmedical gloves. FDA believes that, although 
manufacturers and distributors may experience some loss of revenue from 
this shift (because of the price premium commanded by medical gloves), 
the loss will be inconsequential.
4. Costs of FDA Inspections
    FDA does not envision increased inspection costs due to the final 
rule. The rate of sampled glove lots is not expected to differ and FDA 
resources are not expected to increase over the evaluation period.
5. Total Costs
    In sum, FDA estimates that the final rule will have an average 
annualized cost of about $6.6 million using either a 3 percent or 7 
percent annual discount rate. Table 2 presents the costs for each year 
of the evaluation period.

                            Table 2.--Costs per Year of the Final Rule (in millions)
----------------------------------------------------------------------------------------------------------------
                                                         Costs for Quality      Costs for
                          Year                                Control            Sampling         Total Costs
----------------------------------------------------------------------------------------------------------------
Current                                                               $5.4               $0.4               $5.8
----------------------------------------------------------------------------------------------------------------
1                                                                     $5.6               $0.4               $6.0
----------------------------------------------------------------------------------------------------------------
2                                                                     $5.7               $0.4               $6.1
----------------------------------------------------------------------------------------------------------------
3                                                                     $5.9               $0.4               $6.3
----------------------------------------------------------------------------------------------------------------
4                                                                     $6.0               $0.4               $6.4
----------------------------------------------------------------------------------------------------------------
5                                                                     $6.2               $0.4               $6.6
----------------------------------------------------------------------------------------------------------------

[[Page 75871]]

 
6                                                                     $6.3               $0.4               $6.7
----------------------------------------------------------------------------------------------------------------
7                                                                     $6.5               $0.4               $6.9
----------------------------------------------------------------------------------------------------------------
8                                                                     $6.7               $0.4               $7.1
----------------------------------------------------------------------------------------------------------------
9                                                                     $6.8               $0.5               $7.3
----------------------------------------------------------------------------------------------------------------
10                                                                    $7.0               $0.5               $7.5
----------------------------------------------------------------------------------------------------------------
Present Values                                                    3%-$53.2            3%-$3.6           3%-$56.8
                                                                  7%-$43.4            7%-$2.9           7%-$46.3
----------------------------------------------------------------------------------------------------------------

F. Benefits of the Rule

    The final rule will result in public health gains by reducing the 
frequency of blood-borne pathogen transmissions due to defects in the 
barrier protection provided by medical gloves. Based on an implied 
societal willingness to pay (WTP), FDA expects that an annualized 
monetary benefit of $14.8 million (using a 3 percent discount rate) or 
$15.1 million (using a 7 percent discount rate) will be realized due to 
fewer pathogen transmissions and unnecessary blood screens. Fewer glove 
defects will reduce the cost and anxiety associated with unnecessary 
blood screens (i.e., those that would yield negative results for health 
care personnel). Benefits have been analyzed and discounted using the 
methodology suggested by OMB's Circular A-4 (September 2003).
1. Reductions in the Number of Marketed Defective Gloves
    As noted in the previous paragraphs, FDA has determined that 
approximately 940 million defective gloves are marketed each year in 
the United States, or 2.4 percent of all medical gloves. In the absence 
of this rule, FDA expects that the number of defective medical gloves 
marketed in the United States would increase to 1.21 billion per year 
within 10 years. The final rule will substantially reduce this figure.
    WEAC's analysis of 98,067 medical gloves from 942 sampled lots 
collected in 2000 and 2001 resulted in approximately 3 percent lot 
failures with an AQL of 4.0 (28 lots would fail). This lot failure rate 
was associated with 2,356 defective gloves, or 2.4 percent of the total 
number of sampled gloves. Under the lower AQL of 2.5 in the rule, the 
WEAC analysis concluded that 51 additional lots would fail (a total of 
79 failed lots), increasing the lot failure rate from 2.91 percent to 
8.39 percent.
    As previously mentioned, FDA provides a Level 3 detention status in 
its guidance, ``Surveillance and Detentions Without Physical 
Examination of Surgeon's and or Patient Examination Gloves.'' 
Manufacturers on Level 3 detention are not allowed to import medical 
gloves because they have repeatedly failed analysis. To avoid the 
denial of entry, manufacturers may be expected to hold a sufficient 
number of defective lots from shipment in order to maintain the same 
target lot failure rate (approximately 3 percent) with a new AQL. If 
so, removing the 53 most defective lots in the testing sample would 
result in 26 lot failures from 880 total lots, thereby maintaining the 
original 2.92 percent lot failure rate. This scenario leaves 85,172 
total gloves in the sample, of which 1,512 were defective, resulting in 
a glove defect rate of 1.78 percent. The final rule, therefore, could 
reduce the proportion of marketed defective medical gloves from 2.4 
percent of all marketed gloves to 1.78 percent of all marketed gloves.
    The implications of this expected reduction in defective gloves are 
significant. The current AQL is associated with 940 million glove 
defects during the present year (based on 2004) and within 10 years 
would result in 1.21 billion marketed defective medical gloves. When 
the lower AQL is in place, the current number of defective gloves will 
approximate 700 million and within 10 years will result in 900 million 
defective marketed gloves. The number of defective gloves, therefore, 
should be reduced by more than 25 percent due to the new AQL.
2. Reductions in Blood-Borne Pathogens
    FDA has estimated that there are potentially 4.8 annual 
transmissions of blood-borne pathogens associated with medical glove 
defects (section IV.C of this document). These transmissions include 
2.4 cases of HIV and 2.4 cases of chronic HBV. Because there are 
currently no documented cases of cutaneous transmission of HCV that 
would be affected by improving glove quality levels, this analysis does 
not consider potential HCV transmission.
    a. Reductions in HIV transmission. While the direct relationship 
between defective medical gloves and the transmission of HIV is 
unknown, FDA believes it is reasonable to apply the proportional 
reduction in the number of defective gloves due to the final rule 
(about 25 percent) to the annual transmission rate of the HIV pathogen 
to health care personnel. In the absence of this rule, the current 
expectation of 2.4 annual cases of HIV transmission to health care 
personnel would likely increase to 3.1 annual cases within 10 years due 
to the expected growth of employment in the health services industry. 
However, with the new AQL in place, FDA forecasts the expected annual 
transmission of HIV to health care personnel to equal 1.8 cases in 
current conditions and 2.3 cases by the 10th evaluation year (based on 
the expected proportionate decrease in marketed defective gloves). Over 
the entire 10-year evaluation period, these assumptions suggest that 
the rule should prevent approximately seven cases of HIV transmission 
to health care personnel.
    b. Reductions in HBV transmissions. Hepatitis B transmissions to 
health care personnel are more common than cutaneous HIV transmissions. 
However, little specific data are available to identify affected 
patient populations and routes of transmission. FDA has estimated that 
as many as 2.4 cutaneous transmissions of chronic HBV may be due to 
defective medical gloves each year. In the absence of this rule, this 
number would be expected to increase to 3.1 annual transmissions within 
10 years, based on the expected employment growth in the health 
services industry.
    Implementation of the final rule should decrease these 
transmissions by about 25 percent. FDA expects 1.8 HBV transmissions 
under current conditions,

[[Page 75872]]

a reduction of 0.6 transmissions from baseline conditions. By the 10th 
evaluation year, FDA expects that there will be 2.3 chronic HBV 
transmissions with the lower AQL, or a total of 0.8 fewer cases. 
Overall, about seven transmissions of chronic HBV will be avoided due 
to the final rule over a 10-year evaluation period.
3. Reductions in the Number of Blood Screening Tests
    As the number of defective gloves marketed in the United States 
decreases due to this rule, corresponding reductions would be expected 
in the number of unnecessary blood screens. FDA contacted several 
research hospitals to ascertain how frequently health care personnel 
identify glove failure as a reason for initiating blood screens. 
Respondents stated that about 5 percent of all glove failures are 
noticed by the user and about 1 percent of these identified failures 
are reported to the facility for additional screening (Ref. 9 and 10). 
Respondents noted that the glove failure could occur prior to patient 
contact. Therefore, the additional screening may apply to the affected 
health care personnel or the patient. The great majority of these 
screens result in negative findings.
    As shown in the previous paragraphs, when the final rule is in 
effect, FDA expects the number of defective gloves marketed to decrease 
from 940 million to 700 million, a reduction of 240 million defective 
gloves. By the 10th year, the number of defective gloves is expected to 
decrease from 1.21 billion to 900 million, a reduction of 310 million 
defective gloves. At the rates of potential identification (5 percent) 
and reports of contact with pathogens (1 percent) obtained from the 
research hospital sector, the final rule should result in 120,000 fewer 
unnecessary blood screens under current conditions (240 million fewer 
defects x 0.05 x 0.01). By the 10th year, 155,000 fewer annual blood 
screens are expected. Over the entire evaluation period, the rule could 
result in over 1.4 million fewer unnecessary blood screens.
4. Cost-Effectiveness of the Final Rule
    We analyzed the cost-effectiveness of the final rule using both the 
cost per transmission of blood-borne pathogen avoided and the cost per 
unnecessary blood screen avoided. The annual numbers of future avoided 
transmissions and tests were compared to the present values of the 
costs for the evaluation period and shown in Table 3. Table 3 shows the 
expected annual reductions in blood-borne pathogens and unnecessary 
blood screens due to the final rule.

      Table 3.--Expected Annual Reductions in Blood-Borne Pathogen
               Transmissions and Unnecessary Blood Screens
------------------------------------------------------------------------
                                                        Reduction in
         Year           Reduction in Blood-Borne     Unnecessary Blood
                          Pathogen Transmission           Screens
------------------------------------------------------------------------
Current                1.2                         120,000
------------------------------------------------------------------------
1                      1.2                         120,000
------------------------------------------------------------------------
2                      1.2                         125,000
------------------------------------------------------------------------
3                      1.4                         135,000
------------------------------------------------------------------------
4                      1.4                         135,000
------------------------------------------------------------------------
5                      1.4                         140,000
------------------------------------------------------------------------
6                      1.4                         145,000
------------------------------------------------------------------------
7                      1.6                         150,000
------------------------------------------------------------------------
8                      1.4                         145,000
------------------------------------------------------------------------
9                      1.6                         155,000
------------------------------------------------------------------------
10                     1.6                         155,000
------------------------------------------------------------------------

    Although these reductions should continue beyond the evaluation 
period, we have analyzed only through the 10th year. Each year's 
expected number of reduced blood-borne pathogen transmissions and 
unnecessary blood screens are discounted (using both a 3 percent annual 
discount rate and a 7 percent annual discount rate) to arrive at an 
equivalent number of reductions if valued during the first evaluation 
year. The present values of the regulatory costs (shown in Table 4) are 
divided by the present values of the expected reductions to arrive at 
the cost per avoided event. This is shown in Table 4.

     Table 4.--Regulatory Cost-Effectiveness per Incidence of Blood-Borne Pathogen Transmission Avoided and
                                        Unnecessary Blood Screen Avoided
----------------------------------------------------------------------------------------------------------------
                                                          Cost per Blood-
 Annual Discount    Present Value of   Present Value of    Borne Pathogen    Present Value of    Cost per Blood
       Rate            Costs (in         Blood-Borne        Avoided (in       Blood Screens      Screen Avoided
                       millions)      Pathogens Avoided      millions)           Avoided
----------------------------------------------------------------------------------------------------------------
3 percent                      $56.8               12.2               $4.7          1,191,000                $48
----------------------------------------------------------------------------------------------------------------
7 percent                      $46.3                9.8               $4.7            971,000                $48
----------------------------------------------------------------------------------------------------------------

    The cost-effectiveness of the final rule is $4.7 million per 
transmission of blood-borne pathogen avoided, or $48 per unnecessary 
blood screen avoided for both discount rates. We note that both 
reductions should occur and the allocation of costs to each outcome 
would reduce the costs per avoided event for both.
5. Value of Avoiding Blood-borne Pathogens
    a. Quality adjusted life-years. The economic literature includes 
many attempts to quantify societal values of health. A widely cited 
methodology assesses wage differentials necessary to attract labor to 
riskier occupations. This research indicates that society appears to be 
WTP approximately $5 million to avoid the probability of a statistical 
death (Refs. 11, 12, and 13). That is, social values appear to show 
that people are WTP a significant amount to reduce even a small risk of 
death; or similarly, to demand significant payments to accept 
marginally higher risks.
    Because this estimate is predominantly based on blue-collar 
occupations that mainly attract males

[[Page 75873]]

between the ages of 30 and 40, FDA adjusted the life-expectancy of a 
35-year-old male to account for future bed and non-bed disability 
(Refs. 14, 15, and 16), and amortized the $5 million (at both 3 percent 
and 7 percent discount rates) over the resulting quality-adjusted life 
span. The results were estimates of $213,000 per quality adjusted life-
year (QALY) using a 3 percent discount rate and $373,000 per QALY using 
a 7 percent discount rate, which implies that society is WTP between 
$213,000 and $373,000 for the statistical probability of a year of 
perfect health, depending on the discount rate.
    b. Value of morbidity losses. In theory, loss of health reduces the 
willingness to pay for additional longevity. Many studies have 
attempted to estimate the relative loss of health for many different 
conditions of morbidity. One method utilizes the Kaplan-Bush Index of 
Well-Being. This index assigns relative weights to functional states, 
and then adjusts the resulting weighted value by the problem/symptom 
complex that contributed to loss of function (Refs. 16 and 17). 
Functional state is measured in three areas: Mobility, social activity, 
and physical activity. For example, with most treatment, chronic HBV is 
unlikely to have a major impact on any of these functions; a patient 
could drive a car, walk without a physical problem, and conduct work, 
school, housework and other activities. However, because a patient with 
HBV has an ongoing problem/symptom complex the relative weight of this 
functional state is 0.7433\2\.
---------------------------------------------------------------------------

    \2\The implication is that an ideal health state is valued as 
1.0000 and mortality at 0.0000. Each functional state between these 
extremes is a proportionate value of ``perfect'' health.
---------------------------------------------------------------------------

    This methodology then adjusts the weighted value of the functional 
state by the most severe problem/symptom complex contributing to that 
state. In the case of chronic HBV, the most common symptom is general 
tiredness, weakness, or weight loss. This complex has a derived 
relative weight of +0.0027, which when added to the weighted functional 
state value results in a relative weight of 0.7460. The loss of 
relative health due to HBV, therefore, is expected to equal 1.0000 
minus 0.7460, or 0.2540 of perfect health. When this relative health 
loss is applied to the derived value of a QALY, it implies that society 
would be WTP between $54,000 (3 percent) and $93,000 (7 percent) per 
year to avoid a case of HBV (QALY value x 0.2540). This value includes 
the potential costs of treatment and additional prevention, as well as 
any perceived pain and suffering.
    FDA compared this methodology to a variety of published estimates 
of preference ratings of morbidity prepared by the Harvard Center for 
Risk Analysis (HCRA) (Ref. 17a). The published ratings of 14 studies of 
chronic HBV ranged from 0.75 to 1.00 (no impact). While the estimate 
used in this analysis (0.746) is in the low end of collected published 
studies, FDA notes that most of the expressed preferences that were 
derived from time trade-off and standard gamble methodologies, as 
compared to author judgment, were closer to the FDA estimate. A health 
care worker who may contract HBV may typically have a life expectancy 
of approximately 40 years (as of 2000, a 40-year-old female had a 
future life expectancy of 41.1 years (Ref. 14)). The present value (PV) 
of $54,000 (3 percent) and $93,000 (7 percent) for 40 years implies 
that society is WTP $1.25 million (3 percent) or $1.24 million (7 
percent) to avoid the statistical likelihood of a case of chronic HBV 
in health care personnel.
    Deriving society's implied WTP to avoid HIV is more complicated. 
The CDC has published data indicating that approximately 80 percent of 
all HIV infections progress to AIDS within 5 years. Of the cases of 
AIDS, over half (approximately 60 percent) result in mortality within 
an additional 5 years. Thus, for a 10-year period, FDA tracked 3 
potential outcomes: Patients who contract HIV but do not progress to 
AIDS (20 percent), patients who contract HIV and progress to AIDS in 5 
years and survive (32 percent), and patients who contract HIV, progress 
to AIDS within 5 years and then die within an additional 5 years (48 
percent).
    HIV infection is not expected to affect either mobility or social 
activity. However, such an infection is likely to somewhat inhibit 
physical activity. HIV patients are expected to be able to walk, but 
with some physical limitations. This functional state has a relative 
weight of 0.6769. The main problem/symptom complex of HIV is general 
tiredness (as for HBV), so the selected functional weight is adjusted 
by +0.0027 to result in relative well-being of 0.6796. As a result, the 
relative societal willingness to pay to avoid the statistical 
probability of a case of HIV in health care personnel is approximately 
$68,000 (3 percent) or $120,000 (7 percent) per year (QALY value x 
[1.0000 minus 0.6796]). According to the collected preference scores 
(ref. 17a) in the HCRA's Catalog of Preference Scores, the average 
estimated published preference rating for HIV infection was 0.7 (range 
0.3 to 1.00).
    If HIV progresses to AIDS, a patient's functional state is likely 
to be more restricted. An AIDS patient requires some assistance with 
transportation, is limited in physical activity, and is limited in 
work, school, or household activity. The relative weight for this 
functional state is 0.5402. The main problem/symptom of AIDS remains 
general tiredness and loss of weight (as with HIV and HBV), so the 
adjusted health state is 0.5429. This results in a derived societal 
willingness to pay to avoid the statistical probability of a case of 
AIDS of about $97,000 (3 percent) or $170,000 (7 percent) per year 
(QALY value x (1.0000 minus 0.5429)). The HCRA's Catalog of Preference 
Scores (ref. 17a) reports average preference ratings of 0.375 for cases 
of AIDS with ranges from 0.0 to 0.5.
    As discussed earlier, the derived societal willingness to pay to 
avoid a statistical mortality has been estimated to equal approximately 
$5 million.
    Using these estimates, the WTP to avoid the statistical probability 
of an HIV transmission in health care personnel is calculated as the 
sum of:
     20 percent of the PV (at 3 percent and 7 percent discount 
rates) of avoiding 40 years of HIV infection.
     32 percent of the sum of the PV of avoiding 5 years of a 
HIV infection plus the PV of avoiding 35 years of AIDS infection 
occurring 5 years in the future.
     48 percent of the sum of the PV of avoiding 5 years of HIV 
infection plus the PV of avoiding 5 years of AIDS infection occurring 5 
years in the future plus the discounted WTP of avoiding a statistical 
mortality occurring 10 years in the future.
    The PV of avoiding 40 years of health loss valued at $68,000 per 
year (3 percent) is approximately $1.6 million and if valued at 
$120,000 per year (7 percent) is also approximately $1.6 million. 
Twenty percent of this figure equals $320,000.
    The PV of avoiding 5 years of health loss to due HIV infection is 
equal to $311,000 (3 percent) or $492,000 (7 percent). The PV of 
avoiding the health loss expected from 35 years of AIDS infection 
(valued at $97,000 (3 percent) and $170,000 (7 percent) per year) is 
equivalent to $2.1 million (3 percent) and $2.2 million (7 percent). 
The present values of these amounts occurring 5 years in the future are 
$1.8 million (3 percent) and $1.6 million (7 percent). When added to 
the PV of avoiding the health loss associated with 5 years of HIV 
infection ($311,000 (3 percent) and $492,000 (7 percent)), the total 
estimated PV of the societal willingness to pay to avoid a statistical 
case of this outcome is about $2.1

[[Page 75874]]

million (for both 3 percent and 7 percent discount rates). Thirty-two 
percent of this figure equals $660,000.
    The PV of avoiding the health loss associated with 5 years of AIDS 
infection ($445,000 (3 percent) and $700,000 (7 percent)) occurring 5 
years in the future is equivalent to $384,000 (3 percent) and $497,000 
(7 percent). The PV of the societal value of avoiding a statistical 
mortality ($5 million) 10 years in the future is $3.72 million (at 3 
percent) and $2.54 million (at 7 percent). The total societal WTP to 
avoid a case of HIV with mortality as an outcome, therefore, is $4.4 
million using a 3 percent discount rate ($311,000 plus $384,000 plus 
$3.72 million) and $3.5 million using a 7 percent discount rate 
($493,000 plus $497,000 plus $2.54 million). Forty-eight percent of 
these figures equals approximately $2.1 million (3 percent) and $1.7 
million (7 percent).
    Summing the weighted amounts of the three expected outcomes for a 
case of HIV infection equals an estimated societal willingness to pay 
of $3.08 million using a 3 percent discount rate ($320,000 plus 
$660,000 plus $2.1 million) and $2.68 million using a 7 percent 
discount rate ($320,000 plus $660,000 plus $1,700,000).
    In sum, the estimated societal values of avoiding morbidity and 
mortality due to transmission of blood-borne pathogens are estimated to 
be equivalent to $1.25 million per transmission of chronic HBV and 
$3.08 million per transmission of HIV using a 3 percent discount rate 
and $1.24 million per transmission of HBV and $2.68 million per 
transmission of HIV using a 7 percent discount rate. FDA notes that 
other cost-effectiveness research (Ref. 18) has determined cost-
effectiveness estimates (excluding pain and suffering) of $2.1 million 
per avoided case of HIV.
    FDA believes the methodology used to estimate the value of avoided 
HBV and HIV infection is reasonable and supportable. However, 
comparative methodologies that demonstrate both higher and lower values 
on avoidance have been reported. FDA acknowledged these differences in 
the proposed rule and solicited comment on other appropriate measures 
for estimating the societal value of avoiding blood-borne pathogens. 
FDA received no responses.
    c. Benefit of morbidity avoidance. The rule is expected to reduce 
both HBV and HIV transmissions by reducing the prevalence of defective 
medical gloves used as barrier protection. During the first evaluation 
year, the rule is expected to result in 0.6 fewer chronic HBV 
transmissions to health care personnel. Applying the assumed societal 
WTPs of $1.25 million (3 percent) and $1.24 million (7 percent) to 
avoid the probability of an HBV infection, the expected benefit of 
avoiding these transmissions is $0.8 million (3 percent) and $0.7 
million (7 percent). By the 10th evaluation year, 0.8 annual 
transmissions are expected to be avoided at a value of $1.0 for either 
discount rate. The PV of avoiding approximately 7 chronic HBV 
transmissions over a 10-year period equals $7.6 million (at 3 percent 
discount rate) and $6.1 million (at 7 percent discount rate). This is 
equal to an average annualized value of $0.9 million for the entire 10-
year evaluation period at either discount rate.
    Also, in the first evaluation year, FDA expects that the final rule 
will result in the probability of 0.6 fewer transmissions of HIV caused 
by defective gloves. Assuming that society is WTP $3.08 million (at 3 
percent discount rate) and $2.68 million (at 7 percent discount rate) 
to avoid the probability of a single HIV transmission, the benefit of 
avoiding these transmissions equals $1.8 million (3 percent) and $1.6 
million (7 percent). By the 10th evaluation year, FDA expects the final 
rule to result in 0.8 fewer HIV transmissions, which are valued at $2.5 
million (3 percent) and $2.1 million (7 percent). The societal PV of 
avoiding seven transmissions of HIV over the 10-year evaluation period 
is $18.8 million (at 3 percent discount rate) and $13.1 million (at 7 
percent discount rate). These values are equivalent to average 
annualized benefits of $2.2 million (at 3 percent discount rate) and 
$1.9 million (at 7 percent discount rate).
    In sum, FDA estimates that the reduction in blood-borne pathogen 
transmissions due to this final rule should produce health benefits 
valued at $3.1 million (at 3 percent discount rate) and $2.8 million 
(at 7 percent discount rate) per year. Most of this benefit (over 67 
percent) is attributable to reducing the incidence of HIV.
6. Value of Avoiding Unnecessary Blood Screens
    The expected decline in the number of defective medical gloves 
should lead to fewer unnecessary blood screens and thereby provide two 
potential benefits. First, the direct cost of conducting screens to 
determine whether the pathogen was transmitted to health care personnel 
should decrease. Second, the psychological anxiety and stress that 
accompanies the possibility that a pathogen was transmitted to an 
individual should also decrease.
    a. Cost of conducting blood screens. FDA has collected data from 
the American Red Cross (Ref. 5) on the costs of conducting blood 
screening tests in order to ensure the safety of the blood supply. 
These estimates include the costs of collection (including personnel, 
needles, bags, and other supplies) at $47.66 per sample; sample testing 
at $25.16 per sample; and overhead at $3.26 per sample. The estimated 
direct testing cost per blood sample is the sum of these amounts, or 
$76 per test.
    b. Anxiety and stress associated with potential transmission of 
pathogens. The psychological literature has noted that levels of 
anxiety and stress impact participation in public health screening 
programs and thereby affect physiological health (Refs. 19, 20, and 
21). Also, patients with high levels of uncertainty about whether they 
have contracted serious, threatening diseases experience heightened 
levels of stress and anxiety until they learn the results of any 
testing screens are negative (Ref. 20). According to one measurement 
scale of well-being, reduced mental lucidity, depression, crying, lack 
of concentration, or other signs of adverse psychological sequelae may 
detract as much as 8 percent from overall feelings of well-being (Ref. 
16) and have outcomes similar to physiological morbidity. Scaling of 
the relative stress caused by events shows that concerns about personal 
health, by themselves, are likely, on average, to contribute 
approximately one-sixth of the total weighting required to trigger a 
major stressful episode (Refs. 20, 21, and 22). Thus, FDA approximates 
that increased stress and anxiety concerning possible exposure to 
pathogens may reduce overall sense of well-being and result in health 
loss of approximately 1.3 percent (0.013).
    As described earlier, FDA has calculated an assumed WTP of $213,000 
(at 3 percent) and $373,000 (at 7 percent) for a statistical QALY. 
These figures imply that the probability of each day of quality 
adjusted life has a social value of about $585 (at 3 percent discount 
rate; $213,000 divided by 365) and $1,020 (at 7 percent discount rate; 
$373,000 divided by 365). If blood test results are usually obtained 
within 24 hours, the resultant loss of societal well-being for each 
test subject is valued at approximately $8 (at 3 percent discount rate; 
$585 x 0.013) and $13 (at 7 percent discount rate, $1,020 x 0.013).
    c. Benefit of test avoidance. By combining avoided direct costs of 
tests and the value of avoided anxiety and stress, FDA estimates that 
the societal benefit of avoiding an unnecessary blood test is $84 per 
sample (at 3 percent discount rate) and $89 per sample (at 7 percent 
discount rate).

[[Page 75875]]

During the first evaluation year, FDA expects that there will be 
120,000 fewer unnecessary blood screens because of the expected 
reduction in defective medical gloves due to the final rule. The 
implied societal WTP to avoid these unnecessary screens is $10.1 
million (3 percent) and $10.7 million (7 percent). During the 10th 
evaluation year, approximately 155,000 fewer unnecessary blood screens 
are expected with a resultant benefit of $13.0 million (3 percent) and 
$14.0 million (7 percent). The PV of each year's reduced cost of 
testing and anxiety totals $100.0 million (at 3 percent discount rate) 
and $86.4 million (at 7 percent discount rate). The average annualized 
equivalent amounts are $11.7 million (3 percent) and $12.3 million (7 
percent). Between 85 percent and 90 percent of the average annualized 
amounts represent reductions in the direct testing costs rather than 
the reduced anxiety associated with possible infection by a contagious 
agent.
7. Total Benefits
    FDA estimates that the final rule will reduce the availability of 
defective medical gloves by over 25 percent, resulting in over 2.8 
billion fewer defective gloves over a 10-year period. During this time, 
FDA expects that the reduction in defective gloves will result in 
approximately 7 fewer cases of chronic HBV, 7 fewer cases of HIV, and 
1.4 million fewer unnecessary blood screens. Based on an implied 
societal WTP, the average annualized benefits of the fewer pathogen 
transmissions and unnecessary blood screens should equal $14.8 million 
(at 3 percent annual discount rate) and $15.1 million (at 7 percent 
discount rate).

G. Conclusion

    As noted in the introduction to the analysis of impacts section, 
FDA is certifying that the final rule will not have a significant 
impact on a substantial number of small entities. We provided the above 
information to explain the costs and benefits of the rule. There are 
currently over 400 manufacturers of medical gloves, a vast majority of 
which are foreign and not covered by the Regulatory Flexibility Act. 
There will be little to no impact on domestic entities. Moreover, FDA 
does not expect any increased manufacturer costs to be directly passed 
on to end users because the cost increases will affect only a minority 
of global manufacturers and, therefore, competition will likely force 
these manufacturers to absorb these costs.
    The estimated annualized costs equal $6.6 million using either a 3 
percent annual discount rate or a 7 percent annual discount rate. 
Benefits of avoiding transmissions of blood-borne pathogens and 
unnecessary blood screens have been estimated to equal $14.8 million 
(using a 3 percent discount rate) or $15.1 million (using a 7 percent 
discount rate). The final rule is estimated to result in average 
annualized net benefits of $8.2 million (using a 3 percent discount 
rate) or $8.5 million (using a 7 percent discount rate).

IV. Paperwork Reduction Act of 1995

    This final rule contains no collections of information that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520). The information collection described in 
this rule regarding testing to establish the reconditioning of 
adulterated gloves is exempted from the requirements of the PRA under 5 
CFR 1320.4(a)(2) and (c): The rule describes testing to be conducted on 
specific lots of adulterated gloves ``during the conduct of an 
administrative action, investigation, or audit involving the agency 
against specific individuals'' (1320.4(a)(2)) and ``after a case file 
or equivalent is opened with respect to a particular party'' 
(1320.4(c)).

V. References

    The following references have been placed on display in the 
Division of Dockets Management and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the 
Web site addresses, but is not responsible for subsequent changes to 
the Web site after this document publishes in the Federal Register.
    1. U.S. Centers for Disease Prevention and Control, ``HIV/AIDS 
Fact Sheet,'' www.cdc.gov, 2002.
    2. U.S. Centers for Disease Prevention and Control, 
``Surveillance of Health Care Workers with HIV/AIDS,'' www.cdc.gov, 
2001.
    3. U.S. Centers for Disease Prevention and Control, ``Hepatitis 
Fact Sheet,'' www.cdc.gov, 2002.
    4. U.S. Centers for Disease Prevention and Control, ``Updated 
U.S. Public Health Service Guidelines for the Management of 
Occupational Exposures to HBV, HCV, and HIV and Recommendations for 
Postexposure Prophylaxis,'' Morbidity and Mortality Weekly Report, 
July 17, 2002.
    5. American Red Cross, Washington Post, June 12, 2001.
    6. U.S. International Trade Commission, ``Import Statistics,'' 
www.itc.gov, 2001.
    7. Eastern Research Group, ``Labeling and Related Testing Costs 
for Medical Glove Manufacturers,'' April 17, 2002.
    8. U.S. Bureau of Labor Statistics, ``Industrial Outlooks,'' 
www.bls.gov, 2002.
    9. Bonel, L., Johns Hopkins University, correspondence with John 
Farnham, July 12, 2002.
    10. Budnick, L., Michigan State University, correspondence with 
John Farnham, July 19, 2002.
    11. Viscusi, K., ``Fatal Tradeoffs: Public and Private 
Responsibilities for Risk,'' Oxford University Press, 1992.
    12. Fisher, A., L. Chestnut, et al., ``The Value of Reducing 
Risks of Death: A Note on New Evidence,'' Journal of Policy, 
Analysis, and Management, 8(1):88-100, 1989.
    13. Mudarri D., EPA, ``The Costs and Benefits of Smoking 
Restrictions: An Assessment of the Smoke-Free Environment Act of 
1993,'' (HR 3434), 1994.
    14. U.S. National Center for Health Statistics, ``Vital 
Statistics of the United States,'' 2002.
    15. Chen M., J. Bush, et al., ``Social Indicators for Health 
Planning and Policy Analysis,'' Policy Sciences, 6:71-89, 1975.
    16. Kaplan R., J. Bush, et al., ``Health Status: Types of 
Validity and the Index of Well-Being,'' Health Services Research, 
winter, 478-507, 1976.
    17. Kaplan R., J. Bush, ``Health Related Quality of Life 
Measurement for Evaluation Research and Policy Analysis,'' Health 
Psychology, 1(1):61-80, 1982.
    17a. Harvard Center for Risk Analysis, 2002, ``CUA Database: 
Catalog of Preference Scores,'' Harvard School of Public Health, 
www.hcra.harvard.edu/pdf/preferencescores/pdf, accessed October 26, 
2002.
    18. Marin M., J. Van Lieu, et al., ``Cost-Effectiveness of a 
Post-Exposure HIV Chemoprophylaxis Program for Blood Exposures in 
Health Care Workers,'' Journal of Occupational and Environmental 
Medicine, 41:9, 754-60, 1999.
    19. Radloff L., ``The CES-D Scale: A Self-Report Depression 
Scale for Research in the General Population,'' Applied 
Psychological Measurement, 1(3):385-401, 1977.
    20. Shrout, P., ``The Scaling of Stressful Life Events,'' (in) 
Stressful Life Events and Their Contents, B.S. Dohrenwend and B.P. 
Dohrenwend (eds), Rutgers University Press, 1984.
    21. Holmes, T. and R. Rahe, ``The Social Readjustment Rating 
Scale,'' Journal of Psychosomatic Research, 11:213-218, 1967.
    22. Davis M., E. Eshelman, et al., ``The Relaxation and Stress 
Reduction Workbook,'' MJF Books, 1995.

List of Subjects in 21 CFR Part 800

    Administrative practice and procedure, Medical devices, Opthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
800 is amended as follows:

PART 800--GENERAL

0
1. The authority citation for 21 CFR part 800 continues to read as 
follows:


[[Page 75876]]


    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

0
2. Section 800.20 is amended by revising paragraphs (b), (c), and (d) 
to read as follows:


Sec.  800.20  Patient examination gloves and surgeons' gloves; sample 
plans and test method for leakage defects; adulteration.

* * * * *
    (b)(1) General test method. For the purposes of this part, FDA's 
analysis of gloves for leaks and visual defects will be conducted by a 
visual examination and by a water leak test method, using 1,000 
milliliters (ml) of water.
    (i) Units examined. Each medical glove will be analyzed 
independently. When packaged as pairs, each glove is considered 
separately, and both gloves will be analyzed.
    (ii) Identification of defects. For this test, defects include 
leaks detected when tested in accordance with paragraph (b)(3) of this 
section. A leak is defined as the appearance of water on the outside of 
the glove. This emergence of water from the glove constitutes a 
watertight barrier failure. Other defects include tears, embedded 
foreign objects, extrusions of glove material on the exterior or 
interior surface of the glove, gloves that are fused together so that 
individual glove separation is impossible, gloves that adhere to each 
other and tear when separated, or other visual defects that are likely 
to affect the barrier integrity.
    (iii) Factors for counting defects. One defect in one glove is 
counted as one defect. A defect in both gloves in a pair of gloves is 
counted as two defects. If multiple defects, as defined in paragraph 
(b)(1)(ii) of this section, are found in one glove, they are counted as 
one defect. Visual defects and leaks that are observed in the top 40 
millimeters (mm) of a glove will not be counted as a defect for the 
purposes of this part.
    (2) Leak test materials. FDA considers the following to be the 
minimum materials required for this test :
    (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one 
end and a mark scored 40 mm from the other end (a cylinder of another 
size may be used if it accommodates both cuff diameter and any water 
above the glove capacity);
    (ii) Elastic strapping with velcro or other fastening material;
    (iii) Automatic water-dispensing apparatus or manual device capable 
of delivering 1,000 ml of water;
    (iv) Stand with horizontal rod for hanging the hook end of the 
plastic tube. The horizontal support rod must be capable of holding the 
weight of the total number of gloves that will be suspended at any one 
time, e.g., five gloves suspended will weigh about 5 kilograms (kg);
    (v) Timer capable of measuring two minute intervals.
    (3) Visual defects and leak test procedures. Examine the sample and 
identify code/lot number, size, and brand as appropriate. Continue the 
visual examination using the following procedures:
    (i) Visual defects examination. Inspect the gloves for visual 
defects by carefully removing the glove from the wrapper, box, or 
package. Visually examine each glove for defects. As noted in paragraph 
(b)(1)(iii) of this section, a visual defect observed in the top 40 mm 
of a glove will not be counted as a defect for the purpose of this 
part. Visually defective gloves do not require further testing, 
although they must be included in the total number of defective gloves 
counted for the sample.
    (ii) Leak test set-up. (A) During this procedure, ensure that the 
exterior of the glove remains dry. Attach the glove to the plastic fill 
tube by bringing the cuff end to the 40 mm mark and fastening with 
elastic strapping to make a watertight seal.
    (B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 
(deg)C) into the open end of the fill tube. The water should pass 
freely into the glove. (With some larger sizes of long-cuffed surgeons' 
gloves, the water level may reach only the base of the thumb. With some 
smaller gloves, the water level may extend several inches up the fill 
tube.)
    (iii) Leak test examination. Immediately after adding the water, 
examine the glove for water leaks. Do not squeeze the glove; use only 
minimum manipulation to spread the fingers to check for leaks. Water 
drops may be blotted to confirm leaking.
    (A) If the glove does not leak immediately, keep the glove/filling 
tube assembly upright and hang the assembly vertically from the 
horizontal rod, using the wire hook on the open end of the fill tube 
(do not support the filled glove while transferring).
    (B) Make a second observation for leaks 2 minutes after the water 
is added to the glove. Use only minimum manipulation of the fingers to 
check for leaks.
    (C) Record the number of defective gloves.
    (c) Sampling, inspection, acceptance, and adulteration. In 
performing the test for leaks and other visual defects described in 
paragraph (b) of this section, FDA will collect and inspect samples of 
medical gloves, and determine when the gloves are acceptable as set out 
in paragraphs (c)(1) through (c)(3) of this section.
    (1) Sample plans. FDA will collect samples from lots of medical 
gloves in accordance with agency sampling plans. These plans are based 
on sample sizes, levels of sample inspection, and acceptable quality 
levels (AQLs) found in the International Standard Organization's 
standard ISO 2859, ``Sampling Procedures For Inspection By 
Attributes.''
    (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use 
single normal sampling for lots of 1,200 gloves or less and multiple 
normal sampling for all larger lots. FDA will use general inspection 
level II in determining the sample size for any lot size. As shown in 
the tables following paragraph (c)(3) of this section, FDA considers a 
1.5 AQL to be the minimum level of quality acceptable for surgeons' 
gloves and a 2.5 AQL to be the minimum level of quality acceptable for 
patient examination gloves.
    (3) Adulteration levels and accept/reject criteria. FDA considers a 
lot of medical gloves to be adulterated when the number of defective 
gloves found in the tested sample meets or exceeds the applicable 
rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for 
patient examination gloves. These acceptance and rejection numbers are 
identified in the tables following paragraph (c)(3) of this section as 
follows:

                                                 Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Number Defective
                      Lot Size                                Sample             Sample Size      Number Examined  -------------------------------------
                                                                                                                          Accept             Reject
--------------------------------------------------------------------------------------------------------------------------------------------------------
8 to 90                                                        Single sample  .................                  8                  0                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
91 to 280                                                      Single sample  .................                 32                  1                  2
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 75877]]

 
281 to 500                                                     Single sample  .................                 50                  2                  3
--------------------------------------------------------------------------------------------------------------------------------------------------------
501 to 1,200                                                   Single sample  .................                 80                  3                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,201 to 3,200                                                         First                 32                 32                 --                  4
                                                                      Second                 32                 64                  1                  5
                                                                       Third                 32                 96                  2                  6
                                                                      Fourth                 32                128                  3                  7
                                                                       Fifth                 32                160                  5                  8
                                                                       Sixth                 32                192                  7                  9
                                                                     Seventh                 32                224                  9                 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,201 to 10,000                                                        First                 50                 50                  0                  4
                                                                      Second                 50                100                  1                  6
                                                                       Third                 50                150                  3                  8
                                                                      Fourth                 50                200                  5                 10
                                                                       Fifth                 50                250                  7                 11
                                                                       Sixth                 50                300                 10                 12
                                                                     Seventh                 50                350                 13                 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
10,001 to 35,000                                                       First                 80                 80                  0                  5
                                                                      Second                 80                160                  3                  8
                                                                       Third                 80                240                  6                 10
                                                                      Fourth                 80                320                  8                 13
                                                                       Fifth                 80                400                 11                 15
                                                                       Sixth                 80                480                 14                 17
                                                                     Seventh                 80                560                 18                 19
--------------------------------------------------------------------------------------------------------------------------------------------------------
35,000                                                                 First                125                125                  1                  7
                                                                      Second                125                250                  4                 10
                                                                       Third                125                375                  8                 13
                                                                      Fourth                125                500                 12                 17
                                                                       Fifth                125                625                 17                 20
                                                                       Sixth                125                750                 21                 23
                                                                     Seventh                125                875                 25                 26
--------------------------------------------------------------------------------------------------------------------------------------------------------


                        Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
     Lot Size            Sample          Sample Size      Number Examined  -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
5 to 50                Single sample  .................                  5                  0                  1
----------------------------------------------------------------------------------------------------------------
51 to 150              Single sample  .................                 20                  1                  2
----------------------------------------------------------------------------------------------------------------
151 to 280             Single sample  .................                 32                  2                  3
----------------------------------------------------------------------------------------------------------------
281 to 500             Single sample  .................                 50                  3                  4
----------------------------------------------------------------------------------------------------------------
501 to 1,200           Single sample  .................                 80                  5                  6
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                 First                 32                 32                  0                  4
                              Second                 32                 64                  1                  6
                               Third                 32                 96                  3                  8
                              Fourth                 32                128                  5                 10
                               Fifth                 32                160                  7                 11
                               Sixth                 32                192                 10                 12
                             Seventh                 32                224                 13                 14
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                First                 50                 50                  0                  5
                              Second                 50                100                  3                  8
                               Third                 50                150                  6                 10
                              Fourth                 50                200                  8                 13
                               Fifth                 50                250                 11                 15
                               Sixth                 50                300                 14                 17
                             Seventh                 50                350                 18                 19
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000               First                 80                 80                  1                  7
                              Second                 80                160                  4                 10

[[Page 75878]]

 
                               Third                 80                240                  8                 13
                              Fourth                 80                320                 12                 17
                               Fifth                 80                400                 17                 20
                               Sixth                 80                480                 21                 23
                             Seventh                 80                560                 25                 26
----------------------------------------------------------------------------------------------------------------
35,000 and above               First                125                125                  2                  9
                              Second                125                250                  7                 14
                               Third                125                375                 13                 19
                              Fourth                125                500                 19                 25
                               Fifth                125                625                 25                 29
                               Sixth                125                750                 31                 33
                             Seventh                125                875                 37                 38
----------------------------------------------------------------------------------------------------------------

    (d) Compliance. Lots of gloves that are sampled, tested, and 
rejected using procedures in paragraphs (b) and (c) of this section, 
are considered adulterated within the meaning of section 501(c) of the 
act.
    (1) Detention and seizure. Lots of gloves that are adulterated 
under section 501(c) of the act are subject to administrative and 
judicial action, such as detention of imported products and seizure of 
domestic products.
    (2) Reconditioning. FDA may authorize the owner of the product, or 
the owner's representative, to attempt to recondition, i.e., bring into 
compliance with the act, a lot or part of a lot of foreign gloves 
detained at importation, or a lot or part of a lot of seized domestic 
gloves.
    (i) Modified sampling, inspection, and acceptance. If FDA 
authorizes reconditioning of a lot or portion of a lot of adulterated 
gloves, testing to confirm that the reconditioned gloves meet AQLs must 
be performed by an independent testing facility. The following 
tightened sampling plan must be followed, as described in ISO 2859 
``Sampling Procedures for Inspection by Attributes:''
    (A) General inspection level II,
    (B) Single sampling plans for tightened inspection,
    (C) 1.5 AQL for surgeons' gloves, and
    (D) 2.5 AQL for patient examination gloves.
    (ii) Adulteration levels and acceptance criteria for reconditioned 
gloves. (A) FDA considers a lot or part of a lot of adulterated gloves, 
that is reconditioned in accordance with paragraph (d)(2)(i) of this 
section, to be acceptable when the number of defective gloves found in 
the tested sample does not exceed the acceptance number in the 
appropriate tables in paragraph (d)(2)(ii)(B) of this section for 
reconditioned surgeons' gloves or patient examination gloves.
    (B) FDA considers a reconditioned lot of medical gloves to be 
adulterated within the meaning of section 501(c) of the act when the 
number of defective gloves found in the tested sample meets or exceeds 
the applicable rejection number in the tables following paragraph 
(d)(2)(ii)(B) of this section:

                      Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
              Lot Size                      Sample          Sample Size    -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
13 to 90                                  Single sample                 13                  0                  1
----------------------------------------------------------------------------------------------------------------
91 to 500                                 Single sample                 50                  1                  2
----------------------------------------------------------------------------------------------------------------
501 to 1,200                              Single sample                 80                  2                  3
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                            Single sample                125                  3                  4
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                           Single sample                200                  5                  6
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000                          Single sample                315                  8                  9
----------------------------------------------------------------------------------------------------------------
35,000 and above                          Single sample                500                 12                 13
----------------------------------------------------------------------------------------------------------------


                 Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
              Lot Size                      Sample          Sample Size    -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
8 to 50                                   Single sample                  8                  0                  1
----------------------------------------------------------------------------------------------------------------
51 to 280                                 Single sample                 32                  1                  2
----------------------------------------------------------------------------------------------------------------

[[Page 75879]]

 
281 to 500                                Single sample                 50                  2                  3
----------------------------------------------------------------------------------------------------------------
501 to 1,200                              Single sample                 80                  3                  4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                            Single sample                125                  5                  6
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                           Single sample                200                  8                  9
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000                          Single sample                315                 12                 13
----------------------------------------------------------------------------------------------------------------
35,000 and above                          Single sample                500                 18                 19
----------------------------------------------------------------------------------------------------------------


    Dated: December 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21591 Filed 12-18-06; 8:45 am]
BILLING CODE 4160-01-S