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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 K942149
Device Name POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES
Applicant
Ti-Mate Prophylactic Devices , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Applicant Contact SANJAY MUNSHI
Correspondent
Ti-Mate Prophylactic Devices , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Correspondent Contact SANJAY MUNSHI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/03/1994
Decision Date 10/13/1994
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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