510(k) Report

FDA applicant

Quality Latex Corp. Sdn Bhd

Malaysia, MY2 decisions1989–19990 recalls

FDA records 2 decisions for Quality Latex Corp. Sdn Bhd (Malaysia, MY) from 1989 to 1999: 2 510(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 Quality Latex Corp. Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality Latex Corp. Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quality Latex Corp. 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 Glove2decisions

What has FDA decided for it lately?

  • K993271Quality Latex Powdered Latex Medical Gloves with Protein Content Labeling Claim of 170 Microgram or LessQuality Latex Corp. Sdn Bhd · 1999
  • K893075Patient Examination GlovesQuality Latex Corp. Sdn Bhd · 1989

All 2 as Quality Latex Corp. Sdn Bhd →