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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 K023236
Device Name SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
Applicant
Maxxim Medical
308 Church St.
Hone Path,  SC  29654
Applicant Contact ROY E MOSER
Correspondent
Maxxim Medical
308 Church St.
Hone Path,  SC  29654
Correspondent Contact ROY E MOSER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/27/2002
Decision Date 11/12/2002
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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