510(k) Report

FDA applicant

Apl Products Sdn. Bhd.

Ayer Tawar,Perak Darul Ridzuan, MY3 decisions1999–20020 recalls

FDA records 3 decisions for Apl Products Sdn. Bhd. (Ayer Tawar,Perak Darul Ridzuan, MY) from 1999 to 2002: 3 510(k) clearances. All are in product code 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 Apl Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apl Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apl Products 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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