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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 K893346
Device Name LATEX EXAMINATION GLOVES
Applicant
Avt Rubber Products , Ltd.
Plot No 14-C, Cochin Export
Thrikkakara, Kakkanad, Cochin
682 026, India,  IN
Applicant Contact RAVI KUMAR
Correspondent
Avt Rubber Products , Ltd.
Plot No 14-C, Cochin Export
Thrikkakara, Kakkanad, Cochin
682 026, India,  IN
Correspondent Contact RAVI KUMAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/20/1989
Decision Date 08/24/1989
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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