POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).

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 (pink, Green, Orange,white)..

Pre-market Notification Details

Device IDK090412
510k NumberK090412
Device Name:POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
ClassificationPolymer Patient Examination Glove
Applicant GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang,  MY 42100
ContactFoo Khon Pu
CorrespondentFoo Khon Pu
GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang,  MY 42100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-18
Decision Date2009-06-01

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