POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

Polymer Patient Examination Glove

QUALITY GALLANT SDN. BHD.

The following data is part of a premarket notification filed by Quality Gallant Sdn. Bhd. with the FDA for Powder Free Nitrile (blue And White) Examination Gloves.

Pre-market Notification Details

Device IDK081592
510k NumberK081592
Device Name:POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak,  MY 34700
ContactSeah Bee Hoon
CorrespondentSeah Bee Hoon
QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak,  MY 34700
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-06
Decision Date2008-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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D79010240013 K081592 000

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