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          Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care SettingsSearch for FDA Guidance Documents 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


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

                                                                                  Content current as of:
      08/22/2018
         
                  
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