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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 K895641
Device Name NIL PATIENT EXAMINATION GLOVES
Applicant
United Lion Rubber Industries Sdn. Bhd.
Lot 20, Jalan Pengapit 15/19
Shah Alam,  MY 40000
Applicant Contact CHAI WAH
Correspondent
United Lion Rubber Industries Sdn. Bhd.
Lot 20, Jalan Pengapit 15/19
Shah Alam,  MY 40000
Correspondent Contact CHAI WAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/19/1989
Decision Date 10/04/1989
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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