510(k) Report

FDA applicant

Starmatrix Sdn Bhd

Petaling Jaya, Selangor, MY4 decisions2003–20030 recalls

FDA records 4 decisions for Starmatrix Sdn Bhd (Petaling Jaya, Selangor, MY) in 2003: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). 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 Starmatrix Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Starmatrix Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Starmatrix 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) Report