BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)

Latex 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 Polymer Coated Latex Examination Glove (powder Free).

Pre-market Notification Details

Device IDK990543
510k NumberK990543
Device Name:BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
ClassificationLatex 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 CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-22
Decision Date1999-04-09

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