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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 K900811
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Kenwell International , Ltd.
3-B,Peenya, Ii Phase
Bangalore
Karnataka, Karnataka,  IN 560 058
Applicant Contact S. N BANSAL
Correspondent
Kenwell International , Ltd.
3-B,Peenya, Ii Phase
Bangalore
Karnataka, Karnataka,  IN 560 058
Correspondent Contact S. N BANSAL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/21/1990
Decision Date 03/09/1990
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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