BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)— 510(k) K060402

Substantially Equivalent

Brightway Holdings Sdn. Bhd.

FDA 510(k) clearance K060402 for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR), Substantially Equivalent on 2006-06-09. Applicant: Brightway Holdings Sdn. Bhd..

Clearance details

Applicant: Brightway Holdings Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2006-02-15
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, Selangor Darul Ehsan, MY

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Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.