510(k) Report

FDA applicant

Asia Pacific Latex Sdn Bhd

Ipoh Perak, MY4 decisions1994–20040 recalls

FDA records 4 decisions for Asia Pacific Latex Sdn Bhd (Ipoh Perak, MY) from 1994 to 2004: 4 510(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 Asia Pacific Latex Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Asia Pacific Latex Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove3decisions
  • LZAPolymer Patient Examination Glove1decision

What has FDA decided for it lately?

  • K033532Asia Pacific Latex SDN. BHD. Polymer Coated Powder Free Latex Examination GlovesAsia Pacific Latex Sdn Bhd · 2004
  • K033530Asia Pacific Latex SDN. BHD. Powder Free Latex Examination GlovesAsia Pacific Latex Sdn Bhd · 2004
  • K982274Nitrile Patient Examination Glove Powder FreeAsia Pacific Latex Sdn Bhd · 1998
  • K924357Latex Patient Examination GlovesAsia Pacific Latex Sdn Bhd · 1994

All 4 as Asia Pacific Latex Sdn Bhd →