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

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