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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 K896672
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
U.O.P. Rubber Products Sdn Bhd
878 Jalan Bandar Baru, Nibong
Tebal
Penang,  MY 14300
Applicant Contact BENG CHUAN
Correspondent
U.O.P. Rubber Products Sdn Bhd
878 Jalan Bandar Baru, Nibong
Tebal
Penang,  MY 14300
Correspondent Contact BENG CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/27/1989
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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