BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (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 Nitrile Examination Glove (powder Free).

Pre-market Notification Details

• Device ID: K990541
• 510k Number: K990541
• Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (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: 1999-02-22
• Decision Date: 1999-04-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10850019992882	K990541	000
10850018123485	K990541	000
10850018123508	K990541	000
10850018123522	K990541	000
10850018123546	K990541	000
10850018123560	K990541	000
10850018374207	K990541	000
10850018374221	K990541	000
10850018374245	K990541	000
10850018374269	K990541	000
10850018374283	K990541	000
10850019992806	K990541	000
10850019992820	K990541	000
10850019992844	K990541	000
10850019992868	K990541	000
10850018123461	K990541	000