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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 K121368
Device Name NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
Applicant
MATANG MFG. SDN. BHD.
LOT 10, KAWASAN PERINDUSTRIAN
SERKAM, MUKIM SERKAM
MERLIMAU, MELAKA,  MY 77300
Applicant Contact LESLIE LEONG
Correspondent
MATANG MFG. SDN. BHD.
LOT 10, KAWASAN PERINDUSTRIAN
SERKAM, MUKIM SERKAM
MERLIMAU, MELAKA,  MY 77300
Correspondent Contact LESLIE LEONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/07/2012
Decision Date 08/10/2012
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
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