510(k) Report

FDA applicant

American Healthcare Products (M) Sdn Bhd

Nilai, Negeri Sembilan 71800, MY3 decisions1998–19990 recalls

FDA records 3 decisions for American Healthcare Products (M) Sdn Bhd (Nilai, Negeri Sembilan 71800, MY) from 1998 to 1999: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 American Healthcare Products (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Healthcare Products (M) Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Healthcare Products (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.

See the 510(k) Report

Which product codes does it file in?

  • LYYLatex Patient Examination Glove2decisions
  • LZAPolymer Patient Examination Glove1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982218Nitrile Powder-Free Uniseal GlovesAmerican Healthcare Products (M) Sdn Bhd · 19981cites it

What has FDA decided for it lately?

  • K983614Uniseal Powder-Free Latex Examination Gloves (Blue & Green Colored)American Healthcare Products (M) Sdn Bhd · 1999
  • K981979Uniseal Gloves Low Protein PowderedAmerican Healthcare Products (M) Sdn Bhd · 1998
  • K982218Nitrile Powder-Free Uniseal GlovesAmerican Healthcare Products (M) Sdn Bhd · 1998

All 3 as American Healthcare Products (M) Sdn Bhd →