POWDERED LATEX EXAMINATION GLOVES

Latex 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 Powdered Latex Examination Gloves.

Pre-market Notification Details

Device IDK071323
510k NumberK071323
Device Name:POWDERED LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak,  MY 34700
ContactSeah B Hoon
CorrespondentSeah B Hoon
QUALITY GALLANT SDN. BHD. LOT 1874, JALAN KAMPUNG DEW SIMPANG HALT Taiping, Perak,  MY 34700
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-10
Decision Date2007-06-22
Summary:summary

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