510(k) Report

FDA applicant

Pamitex Industries Sdn Bhd

Darul Khusus, MY19 decisions1999–20010 recalls

FDA records 19 decisions for Pamitex Industries Sdn Bhd (Darul Khusus, MY) from 1999 to 2001: 19 510(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 Pamitex Industries Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pamitex Industries Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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