510(k) Report

FDA applicant

Alcatron Gloves Factory

Weifang, CN2 decisions2011–20220 recalls

FDA records 2 decisions for Alcatron Gloves Factory (Weifang, CN) from 2011 to 2022: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl 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 Alcatron Gloves Factory’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011: 12022: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Alcatron Gloves Factory by year, 2011–2026Sources: 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
  • LYZVinyl Patient Examination Glove1decision

What has FDA decided for it lately?

  • K212998Powder Free Nitrile Examination Gloves (White, Blue and Black)Alcatron Gloves Factory · 2022
  • K112222Alcatron and / or Multiple BrandAlcatron Gloves Factory · 2011

All 2 as Alcatron Gloves Factory →