POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)

Polymer Patient Examination Glove

GX CORPORATION SDN BHD

The following data is part of a premarket notification filed by Gx Corporation Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Orange (orange Scented), White (vanilla Scented).

Pre-market Notification Details

Device IDK092200
510k NumberK092200
Device Name:POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
ClassificationPolymer Patient Examination Glove
Applicant GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor Darul Ehsan,  MY 42100
ContactFoo Khon Pu
CorrespondentFoo Khon Pu
GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor Darul Ehsan,  MY 42100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-22
Decision Date2009-09-16

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