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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 K003350
Device Name HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
Applicant
PAMITEX INDUSTRIES SDN BHD
BATU 2 1/2, JALAN RASAH
SEREMBAN, N.S.,  MY 70300
Applicant Contact SAID AWANG
Correspondent
PAMITEX INDUSTRIES SDN BHD
BATU 2 1/2, JALAN RASAH
SEREMBAN, N.S.,  MY 70300
Correspondent Contact SAID AWANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/26/2000
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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