[Federal Register Volume 64, Number 220 (Tuesday, November 16, 1999)]
[Notices]
[Pages 62208-62209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4487]


Medical Devices; Draft Guidance for Conducting Stability Testing 
to Support an Expiration Date Labeling Claim for Medical Gloves; 
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availability of the draft guidance entitled ``Guidance for Conducting 
Stability Testing to Support an Expiration Date Labeling Claim for 
Medical Gloves.'' This guidance is neither final nor is it in effect at 
this time. This guidance describes the information needed to support an 
expiration date labeling claim for powdered or powder-free, surgeon's 
or patient examination gloves. Expiration dating of medical gloves is 
voluntary at this time. FDA recommends that manufacturers, repackagers, 
or importers who add an expiration date labeling claim follow the 
enclosed recommended criteria and protocols for conducting testing 
described in this guidance.

DATES: Written comments concerning this draft guidance must be received 
by February 14, 2000.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the guidance document entitled, 
``Guidance for Conducting Stability Testing to Support an Expiration 
Date Labeling Claim for Medical Gloves'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 301-443-8818. Written 
comments concerning this guidance must be submitted 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: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION:

I. Background

    It is estimated that millions of health care workers use medical 
gloves on a daily basis as a barrier against blood borne pathogens and 
microorganisms. The effective use of medical gloves as a barrier, 
however, is dependent upon the integrity of the glove material. 
Degradation of the glove material may occur when exposed to various 
types of manufacturing processes (e.g., chlorination) and/or 
environmental conditions.
    In response to growing concerns regarding the use of natural rubber 
latex (NRL), the National Institute of Occupational Safety and Health 
recently issued a safety alert recommending the use of powder-free 
medical gloves as a means to reduce exposure to natural

[[Page 62209]]

rubber latex allergens through the medical glove powder. With the 
present shift in the medical glove market from powdered medical gloves 
to powder-free, the potential for a rapid increase in the demand for 
powder-free or nonpowdered gloves could result in products with poor 
barrier integrity and/or unacceptable shelf-life. Processes to remove 
glove powder such as chlorination have an adverse effect on various 
mechanical and physical glove properties, which may affect shelf-life.
    Expiration dating is not currently required for patient examination 
or surgeon's gloves. However, FDA has just published a proposed 
regulation to require expiration dating for all medical gloves (64 FR 
41709, July 30, 1999). Currently, if manufacturers voluntarily label 
their glove with an expiration date, they are expected to have real-
time data to support the shelf-life labeling claim. If real-time data 
are not available, then a provisional shelf-life labeling claim, not to 
exceed a period of 2 years, may be established based on accelerated 
aging test data. This guidance provides recommended test methodology 
and protocols for both real-time and accelerated aging that the 
manufacturers may utilize to support an expiration date labeling claim. 
Additionally, manufacturers of medical gloves may utilize this guidance 
document to design process controls, as described in the quality system 
regulation, for controlling manufacturing processes, such as 
chlorination, to minimize adverse effects on glove barrier properties.

 II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
conducting stability testing to support an expiration date labeling 
claim for 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 guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the ``Guidance for Conducting Stability Testing 
to Support an Expiration Date Labeling Claim for Medical Gloves'' via 
your fax machine, 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 second voice prompt press 
2, and then enter the document number (1355) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with access to the Internet. Updated on a 
regular basis, the CDRH home page includes ``Guidance for Conducting 
Stability Testing to Support an Expiration Date Labeling Claim for 
Medical Gloves,'' device safety alerts, 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. ``Guidance for Conducting Stability Testing to Support an 
Expiration Date Labeling Claim for Medical Gloves'' will be available 
at http://www.fda.gov/cdrh.

IV. Comments

    Interested persons may, on or before February 14, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft guidance. Such comments will be considered when 
determining whether to amend the current guidance. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance document and 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-29791 Filed 11-15-99; 8:45 am]
BILLING CODE 4160-01-F