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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 K910442
Device Name PATIENT EXAMINATION GLOVES
Applicant
Asian Latex, Ltd.
Yogeshwar M-2, Connaught Pl.
New Delhi-110 001
India,  IN
Applicant Contact DHIRAJ NARANG
Correspondent
Asian Latex, Ltd.
Yogeshwar M-2, Connaught Pl.
New Delhi-110 001
India,  IN
Correspondent Contact DHIRAJ NARANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/31/1991
Decision Date 02/12/1991
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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