510(k) Report

FDA applicant

Masif Healthcare Products Sdn. Bhd.

Ipoh, Perak, Darul Ridzuan, MY4 decisions1989–20000 recalls

FDA records 4 decisions for Masif Healthcare Products Sdn. Bhd. (Ipoh, Perak, Darul Ridzuan, MY) from 1989 to 2000: 4 510(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 Masif Healthcare Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Masif Healthcare Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Masif Healthcare 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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