[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41744-41745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19192]



  Federal Register / Vol. 64, No. 146 / Friday, July 30, 1999 / 
Notices  

[[Page 41744]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2335]


Medical Gloves; Draft Guidance Manual; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Medical Glove Guidance 
Manual.'' The draft guidance represents a major revision of this 
guidance document, which was initially issued in 1993 under the title 
``Guidance for Medical Gloves: A Workshop Manual.'' This draft guidance 
is intended to provide current information to assist manufacturers and 
others in obtaining marketing clearance, applying manufacturing and 
design controls, and properly labeling medical gloves. This draft 
guidance also includes recommendations for limits on the amounts of 
glove powder and natural latex protein present on surgeon's and patient 
examination gloves. Elsewhere in this issue of the Federal Register, 
the FDA is proposing reclassification of surgeon's gloves and patient 
examination gloves into class II (special controls) because the agency 
believes that special controls are necessary to provide reasonable 
assurance of the safety and effectiveness of the gloves. The agency is 
proposing that the draft guidance ``Medical Glove Guidance Manual'' be 
one of the special controls, and the agency is requesting comment on 
the content of the manual at this time.

DATES: Submit written comments concerning this draft guidance by 
October 28, 1999 for consideration prior to implementation of the 
guidance as a special control.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance. Submit written requests for single copies 
on a 3.5'' diskette of the guidance document entitled ``Medical Glove 
Guidance Manual'' to the Division of Small Manufacturers Assistance'' 
(HFZ-220), Center for Devices and Radiological, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. Submit written comments 
concerning this guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Comments should be identified with the docket number found in 
brackets in the heading of this document.

 FOR FURTHER INFORMATION CONTACT: Arthur K. Yellin, Center for Devices 
and Radiological Health (HFZ-200), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 800-638-2041, ext. 146, 301-443-6597, 
ext. 146.
SUPPLEMENTARY INFORMATION:

I. Background

     Medical gloves are a significant factor in the protection of both 
patients and health care personnel in the United States. Because of the 
increased reliance on medical gloves as a barrier against transmission 
of infectious diseases and contaminants, it is imperative that they be 
manufactured and labeled in accordance with FDA laws and regulations.
     Originally entitled ``Guidance for Medical Gloves: A Workshop 
Manual,'' this document was first published in May 1993 to assist 
manufacturers in preparing premarket notification (510(k)) submissions 
for medical gloves and applying quality systems requirements (formerly 
known as good manufacturing practices, or GMP) to the production of 
medical gloves. It has been used extensively as a text in training 
workshops provided by the FDA to the regulated industry. It is heavily 
relied upon and widely recognized as a valuable resource to those 
currently in, or seeking to enter, the United States medical glove 
market.
     The draft guidance has been revised to address and emphasize the 
agency's growing concerns about the role of glove powder as a cause of 
foreign body reactions and as a carrier of airborne natural latex 
allergens. The draft guidance recommends that manufacturers of powdered 
surgeon's and patient examination gloves limit the amount of powder to 
no more than 120 milligrams (mg) of powder per glove, regardless of 
glove size. It further recommends that manufacturers of powder-free 
surgeon's and patient examination gloves limit the amount of total 
trace (residual) powder on gloves to no more than 2 mg particulate 
weight (based on the American Society for Testing Materials Standard 
Test Method for Residual Powder on Medical Gloves (D 6124-97)) per 
glove, regardless of glove size.
     The draft guidance also includes a recommendation that 
manufacturers of natural rubber latex surgeon's and patient examination 
gloves limit the amount of water-extractable protein on the gloves to 
no more than 1200 micrograms of protein per glove, regardless of glove 
size.

II. Significance of Guidance

     This draft guidance represents the agency's current thinking on 
medical gloves. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the applicable statute, 
regulations, or both.
     The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

     Persons interested in obtaining a copy of the medical glove 
guidance manual may do so using the World Wide Web (WWW). CDRH 
maintains an entry on the WWW for access to information including text, 
graphics, and files that may be downloaded to a personal computer with 
access to the WWW. Updated on a regular basis, the CDRH home page 
includes the medical glove guidance manual, device safety alerts, 
access to Federal Register reprints, information on premarket 
submissions including lists of approved applications and manufacturers' 
addresses, small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
``http://www.fda.gov/cdrh''. The medical glove guidance manual is 
available at``http://www.fda.gov/cdrh/manual/glovmanl.pdf''.
     You may also receive instructions about obtaining the medical 
glove guidance manual via your fax machine. To do so call the CDRH 
Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. At the first voice prompt, press 1 to access DSMA 
Facts, at the second voice prompt, press 2, and then enter the document 
number (852) followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.

IV. Comments

     Interested persons may, on or before October 28, 1999 submit to 
Dockets Management Branch (address above) written comments regarding 
this draft guidance. Two copies of any comments are to be submitted, 
except that

[[Page 41745]]

individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19192 Filed 7-29-99; 8:45 am]
BILLING CODE 4160-01-F