BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)

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 Blue Nitrile Examination Gloves (powder Free).

Pre-market Notification Details

Device IDK990878
510k NumberK990878
Device Name:BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
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 Received1999-03-16
Decision Date1999-05-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10036000628200 K990878 000
10850018374146 K990878 000
10850018374160 K990878 000
10850018374184 K990878 000
10850018374627 K990878 000
10850018374641 K990878 000
10850018374665 K990878 000
10850018374689 K990878 000
10850018374702 K990878 000
10850018374726 K990878 000
10850018374122 K990878 000
10850018374108 K990878 000
10036000628217 K990878 000
10036000628224 K990878 000
10036000628231 K990878 000
10850018123584 K990878 000
10850018123607 K990878 000
10850018123621 K990878 000
10850018123645 K990878 000
10850018123669 K990878 000
10850018123683 K990878 000
10850019992707 K990878 000
10850019992721 K990878 000
10850020255761 K990878 000
10850020255785 K990878 000
10850020255808 K990878 000
10850020255822 K990878 000
10850020255846 K990878 000
10850020255860 K990878 000
10850020255884 K990878 000
10850020255907 K990878 000
10850020255921 K990878 000
10850020255747 K990878 000
10850020255723 K990878 000
10850019992745 K990878 000
10850019992769 K990878 000
10850019992783 K990878 000
10850020255266 K990878 000
10850020255280 K990878 000
10850020255303 K990878 000
10850020255327 K990878 000
10850020255341 K990878 000
10850020255365 K990878 000
10850020255945 K990878 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.