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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 K011563
Device Name POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
Applicant
U.O.P. Rubber Products Sdn Bhd
878 Jalan Bandar Baru, Nibong
Tebal
Penang,  MY 14300
Applicant Contact CHUA BENG CHUAN
Correspondent
U.O.P. Rubber Products Sdn Bhd
878 Jalan Bandar Baru, Nibong
Tebal
Penang,  MY 14300
Correspondent Contact CHUA BENG CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/21/2001
Decision Date 06/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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