510(k) Report

FDA applicant

U.O.P. Rubber Products Sdn Bhd

Penang, MY2 decisions1990–20010 recalls

FDA records 2 decisions for U.O.P. Rubber Products Sdn Bhd (Penang, MY) from 1990 to 2001: 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 U.O.P. Rubber Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for U.O.P. Rubber Products Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like U.O.P. Rubber 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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Which product codes does it file in?

  • LYYLatex Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K011563Powder Free Latex Examination Gloves with Water Extractable Protein Labeling ClaimU.O.P. Rubber Products Sdn Bhd · 2001
  • K896672Latex Patient Examination GlovesU.O.P. Rubber Products Sdn Bhd · 1990

All 2 as U.O.P. Rubber Products Sdn Bhd →