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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 K103714
Device Name ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
Applicant
Ansell Healthcare Products, LLC
555 Zang St., Suite 100
Lakewood,  CO  80228
Applicant Contact MARY L ARMSTRONG
Correspondent
Ansell Healthcare Products, LLC
555 Zang St., Suite 100
Lakewood,  CO  80228
Correspondent Contact MARY L ARMSTRONG
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received12/21/2010
Decision Date 07/07/2011
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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