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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K160709
Device Name HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
Applicant
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Gwendolyn George
Correspondent
Halyard Health
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Gwendolyn George
Regulation Number880.6250
Classification Product Code
LZC  
Date Received03/14/2016
Decision Date 09/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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