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HHS/FDA

RIN: 0910-AH02

Publication ID: Spring 2014

Title: Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves
Abstract: FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present a substantial risk of illness that cannot be corrected by a change in labeling. These gloves are Powdered Natural Rubber Latex Surgeon's Gloves, Powdered Synthetic Latex Surgeon's Gloves, Powdered Natural Rubber Latex Patient Examination Gloves, Powdered Synthetic Patient examination gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Consequently, FDA is proposing to ban these devices.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 878 21 CFR 880 21 CFR 895
Legal Authority: 21 USC 352 21 USC 360f 21 USC 360h 21 USC 360i 21 USC 371 ...

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	09/00/2014

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact: Sonja Fulmer Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Building 66, Room 5244, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:240 402-5979 Email: sonja.fulmer@fda.hhs.gov