POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)

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, Tested For Use With Chemotherapy Drugs, Blue (sg).

Pre-market Notification Details

Device IDK102074
510k NumberK102074
Device Name:POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
ClassificationPolymer Patient Examination Glove
Applicant GX CORPORATION SDN BHD LOT 6487A, BATU 5 3/4, SEMENTA JALAN KAPAR Klang, Selangor Darul Ehsan,  MY 42100
ContactCho S Fong
CorrespondentCho S Fong
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 Received2010-07-26
Decision Date2010-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10304040040307 K102074 000
10304040040291 K102074 000
10304040040284 K102074 000
10304040040277 K102074 000
10304040040260 K102074 000
09551005270000 K102074 000

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