510(k) Report

FDA applicant

Medipure Corporation (M) Sdn. Bhd.

Ipoh, Perak, MY2 decisions2000–20060 recalls

FDA records 2 decisions for Medipure Corporation (M) Sdn. Bhd. (Ipoh, Perak, MY) from 2000 to 2006: 2 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Medipure Corporation (M) Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medipure Corporation (M) Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medipure Corporation (M) Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medipure Corporation (M) 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K061551Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 UG…Medipure Corporation (M) Sdn. Bhd. · 2006
  • K001165Polymer Coated Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or…Medipure Corporation (M) Sdn. Bhd. · 2000

All 2 as Medipure Corporation (M) Sdn. Bhd. →