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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K160974
Device Name Gammex Cut-Resistant Glove Liner
Applicant
Ansell Healthcare Products, LLC
111 Wood Ave. S.
Suite 210
Iselin,  NJ  08830
Applicant Contact ROBERT MAHLER
Correspondent
Ansell Healthcare Products, LLC
111 Wood Ave. S.
Suite 210
Iselin,  NJ  08830
Correspondent Contact ROBERT MAHLER
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LYU  
Date Received04/07/2016
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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