FDA applicant

Straitscom

Penang Perai, MY3 decisions1989–19910 recalls

FDA records 3 decisions for Straitscom (Penang Perai, MY) from 1989 to 1991: 3 510(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 Straitscom’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Straitscom since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Straitscom

Which product codes does it file in?

What has FDA decided for it lately?