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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 K081972
Device Name BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
Applicant
NITRITEX (M) SDN. BHD.
KEBUN BARU, JLN MASJID
TELOK PANGLIMA GARANG
KUALA LANGAT, SELANGOR DE,  MY 42500
Applicant Contact DEREK WATTS
Correspondent
NITRITEX (M) SDN. BHD.
KEBUN BARU, JLN MASJID
TELOK PANGLIMA GARANG
KUALA LANGAT, SELANGOR DE,  MY 42500
Correspondent Contact DEREK WATTS
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/10/2008
Decision Date 12/11/2008
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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