BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)

Polymer Patient Examination Glove

BRIGHTWAY HOLDINGS SDN. BHD.

The following data is part of a premarket notification filed by Brightway Holdings Sdn. Bhd. with the FDA for Brightway Brand Colored Powder Free Nitrile Examination Gloves (orange).

Pre-market Notification Details

Device IDK022878
510k NumberK022878
Device Name:BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
ClassificationPolymer Patient Examination Glove
Applicant BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor,  MY 42100
ContactG. Baskaran
CorrespondentG. Baskaran
BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor,  MY 42100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-30
Decision Date2002-09-17

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