Powder Free Nitrile (Black) Examination Gloves

Polymer Patient Examination Glove

GALLANT QUALITY SDN. BHD.

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

Pre-market Notification Details

Device IDK151528
510k NumberK151528
Device Name:Powder Free Nitrile (Black) Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant GALLANT QUALITY SDN. BHD. LOT 1874, JALAN KAMPUNG DEW Taiping,  MY 34700
ContactSumathi Saravana Sami
CorrespondentSumathi Saravana Sami
GALLANT QUALITY SDN. BHD. LOT 1874, JALAN KAMPUNG DEW Taiping,  MY 34700
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-08
Decision Date2015-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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06531950022698 K151528 000
06531950022070 K151528 000

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