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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 K091851
Device Name STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
GX CORPORATION SDN BHD
LOT 6487, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
GX CORPORATION SDN BHD
LOT 6487, BATU 5 3/4, SEMENTA
JALAN KAPAR
KLANG,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/22/2009
Decision Date 12/28/2009
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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