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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 K940576
Device Name PATIENT EXAMINATION GLOVES
Applicant
Vijay Latex Products Private , Ltd.
35, Chandivali Villiage.
Off Saki Vihar Rd.
Bombay-400 072, India,  IN
Applicant Contact JITENDRA R SALOT
Correspondent
Vijay Latex Products Private , Ltd.
35, Chandivali Villiage.
Off Saki Vihar Rd.
Bombay-400 072, India,  IN
Correspondent Contact JITENDRA R SALOT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/08/1994
Decision Date 05/26/1994
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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