Powder Free Blue Nitrile Examination Gloves - Tested For Use With Chemotherapy Drugs

Polymer Patient Examination Glove

Platinum Glove Industries Sdn Bhd

The following data is part of a premarket notification filed by Platinum Glove Industries Sdn Bhd with the FDA for Powder Free Blue Nitrile Examination Gloves - Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK182089
510k NumberK182089
Device Name:Powder Free Blue Nitrile Examination Gloves - Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Platinum Glove Industries Sdn Bhd Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar Selangor Darul Ehsan,  MY 42100
ContactFoo Khon Pu
CorrespondentPoppy Farah Rosa
Platinum Glove Industries Sdn. Bhd. Lot 6491-A, Batu 5 3/4, Sementa, Jalan Kapar Selangor Darul Ehsan,  MY 42100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-02
Decision Date2019-07-30

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