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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 K111139
Device Name DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
Applicant
Ansell Healthcare Products, Inc.
555 Zang St., Suite 100
Lakewood,  CO  80228
Applicant Contact NEIL BURRIS
Correspondent
Ansell Healthcare Products, Inc.
555 Zang St., Suite 100
Lakewood,  CO  80228
Correspondent Contact NEIL BURRIS
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received04/22/2011
Decision Date 09/02/2011
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
Recalls CDRH Recalls
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