510(k) Report

FDA applicant

Kl-Kepong Rubber Products Sdn. Bhd.

Ipoh, MY3 decisions2003–20250 recalls

FDA records 3 decisions for Kl-Kepong Rubber Products Sdn. Bhd. (Ipoh, MY) from 2003 to 2025: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 2 predicates, 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 Kl-Kepong Rubber Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kl-Kepong 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?

  • LZAPolymer Patient Examination Glove2decisions
  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy…Kl-Kepong Rubber Products Sdn. Bhd. · 2025
  • K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination GlovesKl-Kepong Rubber Products Sdn. Bhd. · 2022
  • K023866Powder Free Polymer Coated (Acrylic Based) Patient Examiniation GlovesKl-Kepong Rubber Products Sdn. Bhd. · 2003

All 3 as Kl-Kepong Rubber Products Sdn. Bhd. →