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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 K894324
Device Name LATEX EXAMINATION GLOVES
Applicant
M/S Overseas Latex Pvt. , Ltd.
"Remya", 35/1322
Diwan'S Rd., Cochin
682 016, India,  IN
Applicant Contact MR. G SUBASH
Correspondent
M/S Overseas Latex Pvt. , Ltd.
"Remya", 35/1322
Diwan'S Rd., Cochin
682 016, India,  IN
Correspondent Contact MR. G SUBASH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/14/1989
Decision Date 08/29/1989
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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