STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED— 510(k) K010856

Substantially Equivalent

Brightway Holdings Sdn. Bhd.

FDA 510(k) clearance K010856 for STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED, Substantially Equivalent on 2001-06-06. Applicant: Brightway Holdings Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Brightway Holdings Sdn. Bhd.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Klang, Selangor Darul Ehsan, MY
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