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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 K151694
Device Name Gammex PI Hybrid Surgical Gloves
Applicant
Ansell Healthcare Products, LLC
111 Wood Ave. S.
Suite 210
Iselin,  NJ  08830
Applicant Contact Vasudev Dobariya
Correspondent
Ansell Healthcare Products, LLC
111 Wood Ave. S.
Suite 210
Iselin,  NJ  08830
Correspondent Contact Vasudev Dobariya
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/23/2015
Decision Date 03/09/2016
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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