POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

Polymer Patient Examination Glove

SMART GLOVE CORP. SDN BHD

The following data is part of a premarket notification filed by Smart Glove Corp. Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (blue).

Pre-market Notification Details

Device IDK082370
510k NumberK082370
Device Name:POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
ClassificationPolymer Patient Examination Glove
Applicant SMART GLOVE CORP. SDN BHD LOT 6487 BATU 5 3/4 SEMENTA, JALAN KAPAR Selangor Darul Ehsan,  MY 42100
ContactFoo Khon Pu
CorrespondentFoo Khon Pu
SMART GLOVE CORP. SDN BHD LOT 6487 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 Received2008-08-18
Decision Date2008-10-17

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