[Federal Register Volume 64, Number 208 (Thursday, October 28, 1999)]
[Proposed Rules]
[Page 58004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801, 878, and 880

[Docket No. 98N-0313]


Surgeon's and Patient Examination Gloves; Reclassification; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to January 
27, 2000, the comment period for the proposed rule that appeared in the 
Federal Register of July 30, 1999 (64 FR 41710) . The proposed rule 
would reclassify all surgeon's and patient examination gloves as class 
II medical devices. The agency is taking this action in response to two 
requests for extension of the comment period. This extension of the 
comment period is intended to allow interested persons additional time 
to submit comments on the proposed rule.

DATES: Written comments by January 27, 2000.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices 
and Radiological Health (HFZ-100), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4777.

SUPPLEMENTARY INFORMATION:

I. Extension of Comment Period

     In the Federal Register of July 30, 1999, FDA published a proposed 
rule to reclassify all surgeon's and patient examination gloves as 
class II medical devices. FDA is soliciting comments and information 
from interested persons concerning the reclassification of these 
devices into four categories (powdered surgeon's gloves, powder-free 
surgeon's gloves, powdered patient examination gloves, and powder-free 
patient examination gloves), and it proposed special controls 
consisting of a ``Medical Glove Guidance Manual'' and labeling 
requirements that address protein and powder content.
     FDA received one request from a manufacturer of medical gloves and 
another request from a voluntary standard setting organization to 
extend the comment period an additional 90 days. The manufacturer and 
the voluntary standard setting organization requested additional time 
to allow the American Society for Testing and Materials (ASTM), a 
voluntary standard setting organization, to complete its balloting for 
revisions of its standards to include a recommended maximum powder 
limit in its standards for latex surgeon's gloves, latex patient 
examination gloves, polyvinyl medical gloves, and nitrile patient 
examination gloves. The manufacturer and the voluntary standard setting 
organization wanted the additional time to allow FDA and others to 
consider ASTM's recommendations along with FDA's proposal. In response 
to the letters, FDA is extending the comment period for 90 additional 
days. Elsewhere in this issue of the Federal Register, FDA is 
announcing an extension of the comment period for the draft guidance 
entitled ``Medical Glove Guidance Manual.''

 II. Comments

     Interested persons may, on or before January 27, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding the proposed rule. 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. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 21, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28109 Filed 10-27-99; 8:45 am]
BILLING CODE 4160-01-F