Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

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, [sterling/grey] Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK161215
510k NumberK161215
Device Name:Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant BRIGHTWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang,  MY 42100
ContactG. Baskaran
CorrespondentG. Baskaran
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 Received2016-04-29
Decision Date2016-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10036000507093 K161215 000
10036000507086 K161215 000
10036000507079 K161215 000
10036000507062 K161215 000
10036000507055 K161215 000

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