BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

Patient Examination Glove, Specialty

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 12”, Powder Free, [sterling/grey] With Chemotherapy Claim.

Pre-market Notification Details

• Device ID: K162186
• 510k Number: K162186
• Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
• Classification: Patient Examination Glove, Specialty
• Applicant: BRIGHTWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, MY 42100
• Contact: G. Baskaran
• Correspondent: G. Baskaran; BRIGHTWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, MY 42100
• Product Code: LZC
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-04
• Decision Date: 2017-03-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10036000531418	K162186	000
10036000531401	K162186	000
10036000531395	K162186	000
10036000531388	K162186	000
10036000531371	K162186	000