510(k) Report

FDA applicant

Safetytech Sdn. Bhd.

Jalan Ipoh, 68100 Selang., MY3 decisions1989–19930 recalls

FDA records 3 decisions for Safetytech Sdn. Bhd. (Jalan Ipoh, 68100 Selang., MY) from 1989 to 1993: 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 Safetytech Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safetytech Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Safetytech Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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