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 ID: K990878
• 510k Number: K990878
• Device Name: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
• Classification: Polymer Patient Examination Glove
• Applicant: BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, MY 42100
• Contact: G. Baskaran
• Correspondent: G. Baskaran; BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, Selangor, MY 42100
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-16
• Decision Date: 1999-05-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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