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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 K001239
Device Name ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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 Received04/18/2000
Decision Date 05/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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