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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K935088
Device Name POWDER FREE GLOVES
Applicant
Avt Rubber Products , Ltd.
Plot 14-C, Cochin Export
Processing Zone, Kakkanad
Cochin, Kerala,  IN 682 030
Applicant Contact KURIEN POTHEN
Correspondent
Avt Rubber Products , Ltd.
Plot 14-C, Cochin Export
Processing Zone, Kakkanad
Cochin, Kerala,  IN 682 030
Correspondent Contact KURIEN POTHEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/25/1993
Decision Date 04/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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