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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 K900648
Device Name NIL STERILE LATEX 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 Received02/09/1990
Decision Date 03/08/1990
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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