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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 K992953
Device Name SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
Applicant
Ansell Perry
1875 Harsh Ave. SE
Massillon,  OH  44646
Applicant Contact JAMES R CHATTERTON
Correspondent
Ansell Perry
1875 Harsh Ave. SE
Massillon,  OH  44646
Correspondent Contact JAMES R CHATTERTON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/01/1999
Decision Date 10/29/1999
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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