510(k) Report

FDA applicant

Qube Medical Product Sdn Bhd

Rawang, MY2 decisions2014–20160 recalls

FDA records 2 decisions for Qube Medical Product Sdn Bhd (Rawang, MY) from 2014 to 2016: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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 Qube Medical Product Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Qube Medical Product Sdn Bhd by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove1decision
  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K153732Powder Free Blue Nitrile Examination GloveQube Medical Product Sdn Bhd · 2016
  • K123537Powder Free Latex Examination GlovesQube Medical Product Sdn Bhd · 2014

All 2 as Qube Medical Product Sdn Bhd →