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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 K911134
Device Name SURGICAL GLOVES
Applicant
KENWELL INTERNATIONAL LTD.
3-B,PEENYA, II PHASE
BANGALORE
KARNATAKA, KARNATAKA,  IN 560 058
Applicant Contact S. N BANSAL
Correspondent
KENWELL INTERNATIONAL LTD.
3-B,PEENYA, II PHASE
BANGALORE
KARNATAKA, KARNATAKA,  IN 560 058
Correspondent Contact S. N BANSAL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/14/1991
Decision Date 07/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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