510(k) Report

FDA applicant

Brightsway Holdings Sdn Bhd

Klang Selangor Darul Ehsan, MY4 decisions1999–19990 recalls

FDA records 4 decisions for Brightsway Holdings Sdn Bhd (Klang Selangor Darul Ehsan, MY) in 1999: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Brightsway Holdings Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brightsway Holdings Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Brightsway Holdings Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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