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GUIDANCE DOCUMENT

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Guidance for Industry and Food and Drug Administration Staff December 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2015-D-2261
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Food and Drug Administration (FDA) is issuing this guidance to describe the Agency’s premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by FDA, industry, the standards community, and health care professionals.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-2261.

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