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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 K122131
Model SIZE XS,S,M,L, AND XL
Device Name POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
Applicant
MATANG MFG. SDN. BHD.
lot 10, kawasan perindustrian
serkam, mukim serkam
merlimau, melaka, 
Contact leslie leong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/18/2012
Decision Date 10/17/2012
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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