510(k) Report

FDA applicant

Hl Rubber Products Sdn Bhd

Kuala Lumpur, MY2 decisions1997–20040 recalls

FDA records 2 decisions for Hl Rubber Products Sdn Bhd (Kuala Lumpur, MY) from 1997 to 2004: 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 Hl Rubber Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hl Rubber Products Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hl 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?

  • K040793Felcare Powder Free, Polymer Coated Latex Examination GlovesHl Rubber Products Sdn Bhd · 2004
  • K961634Nil - Powder-Free Latex Examination GlovesHl Rubber Products Sdn Bhd · 1997

All 2 as Hl Rubber Products Sdn Bhd →