[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
