Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate

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, Nitrile Examination Gloves, Powder Free (blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.

Pre-market Notification Details

Device IDK211816
510k NumberK211816
Device Name:Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
ClassificationPolymer Patient Examination Glove
Applicant Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang,  MY 42100
ContactG. Baskaran
CorrespondentGanesh Subramaniam
Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah Klang,  MY 42100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-11
Decision Date2022-11-02

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