FDA applicant
Brightway Holdings Sdn. Bhd.
FDA records 24 decisions for Brightway Holdings Sdn. Bhd. (Klang, Selangor Darul Ehsan, MY) from 1999 to 2022: 24 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 236 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brightway Holdings Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Brightway Holdings Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Brightway”
FDA records each applicant name separately; these may or may not be the same firm.