510(k) Report

FDA applicant

Anhui Anyu Latex Products Co., Ltd.

Bengbu, CN2 decisions2015–20150 recalls

FDA records 2 decisions for Anhui Anyu Latex Products Co., Ltd. (Bengbu, CN) in 2015: 2 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LYY (Latex Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 and plastic surgery panel, where it files most

How often FDA has decided Anhui Anyu Latex Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Anhui Anyu Latex Products Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGOSurgeon'S Gloves1decision
  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K150609Annuy Latex Surgeon's Gloves (Powdered and Powder Free)Anhui Anyu Latex Products Co., Ltd. · 2015
  • K150612Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove…Anhui Anyu Latex Products Co., Ltd. · 2015

All 2 as Anhui Anyu Latex Products Co., Ltd. →