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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 K092072
Device Name POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
Applicant
GX CORPORATION SDN BHD
LOT 6487A, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG, SELANGOR DARUL EHSAN,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
GX CORPORATION SDN BHD
LOT 6487A, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG, SELANGOR DARUL EHSAN,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/08/2009
Decision Date 11/04/2009
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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