510(k) Report

FDA applicant

Quality Latex Products Malaysia Sdn Bhd

Ipoh. Perak, MY1 decision2001–20010 recalls

FDA records 1 decision for Quality Latex Products Malaysia Sdn Bhd (Ipoh. Perak, MY) in 2001: 1 510(k) clearance. 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 Quality Latex Products Malaysia Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality Latex Products Malaysia Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K011995Polymer Coated Latex Medical Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Quality Latex Products Malaysia Sdn Bhd · 2001

The one decision as Quality Latex Products Malaysia Sdn Bhd →