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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 K922769
Device Name STERILE SURGEONS GLOVES -- MODIFICATION
Applicant
Real Latex Pvt. , Ltd.
Henley House, N.M. Marg,
Ballard Estate
Bombay, Maharashtra,  IN 400 038
Applicant Contact GOKAL
Correspondent
Real Latex Pvt. , Ltd.
Henley House, N.M. Marg,
Ballard Estate
Bombay, Maharashtra,  IN 400 038
Correspondent Contact GOKAL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/16/1992
Decision Date 10/06/1992
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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