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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(K) Number K122874
Device Name POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
Applicant
NITRILIST GLOVES MANUFACTURING SDN BHD
pt 197, kawasan perindustrian dioh
kuala pilah, 
Contact lau siong hut
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/19/2012
Decision Date 12/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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