510(k) Report

FDA applicant

Tomarc (M) Sdn Bhd

Kuala Lumpar, MY5 decisions1989–19930 recalls

FDA records 5 decisions for Tomarc (M) Sdn Bhd (Kuala Lumpar, MY) from 1989 to 1993: 5 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and JTN (Susceptibility Test Discs, Antimicrobial). 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 Tomarc (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tomarc (M) Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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