POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR

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, Peppermint Scented, Blue Color.

Pre-market Notification Details

Device IDK070097
510k NumberK070097
Device Name:POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
ClassificationPolymer Patient Examination Glove
Applicant GX CORPORATION SDN BHD LOT 6487, BATU 5 3/4, SEMENTA JALAN KAPAR Klang,  MY 42100
ContactFoo K Pu
CorrespondentFoo K 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 Received2007-01-10
Decision Date2007-03-23

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