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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 K981392
Device Name ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
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 Received04/17/1998
Decision Date 05/11/1998
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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