Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested For Use With The Chemotherapy Drugs

Surgeon's Gloves

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 White Sterilized Polyisoprene Surgical Gloves-tested For Use With The Chemotherapy Drugs.

Pre-market Notification Details

Device IDK200915
510k NumberK200915
Device Name:Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested For Use With The Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant GX Corporation Sdn Bhd Lot 6491 Batu 5 3/4, Sementa Jalan Kapar Klang,  MY 42100
ContactKhon Pu Foo
CorrespondentKhon Pu Foo
GX Corporation Sdn Bhd Lot 6491 Batu 5 3/4, Sementa Jalan Kapar Klang,  MY 42100
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2021-07-09

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