510(k) Report

FDA applicant

One Glove Industrial Sdn Bhd

Taiping, MY4 decisions2022–20220 recalls

FDA records 4 decisions for One Glove Industrial Sdn Bhd (Taiping, MY) in 2022: 4 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. 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 One Glove Industrial Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

4in 2022

2022: 4
2022high 4 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — One Glove Industrial Sdn Bhd by year, 2022–2026Sources: 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 Glove4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 3 of its 4 were faster than that.

What has FDA decided for it lately?

  • K220431Blue Nitrile Powder-Free Patient Examination Glove, Non-SterileOne Glove Industrial Sdn Bhd · 2022
  • K220429Violet Nitrile Powder-Free Patient Examination Glove, Non SterileOne Glove Industrial Sdn Bhd · 2022
  • K220428Black Nitrile Powder-Free Patient Examination Glove, Non-SterileOne Glove Industrial Sdn Bhd · 2022
  • K220427White Nitrile Powder-Free Patient Examination Glove, Non SterileOne Glove Industrial Sdn Bhd · 2022

All 4 as One Glove Industrial Sdn Bhd →