510(k) Report

FDA applicant

Anhui Xinyisheng Medical Technology Co.,Ltd

Suzhou, CN2 decisions2021–20220 recalls

FDA records 2 decisions for Anhui Xinyisheng Medical Technology Co.,Ltd (Suzhou, CN) from 2021 to 2022: 2 510(k) clearances. Most are in product codes LZC (Medical Glove, Specialty) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 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 hospital panel, where it files most

How often FDA has decided Anhui Xinyisheng Medical Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Anhui Xinyisheng Medical Technology Co.,Ltd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZCMedical Glove, Specialty1decision
  • LZAPolymer Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K213325Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsAnhui Xinyisheng Medical Technology Co.,Ltd · 2022
  • K213371Disposable Medical Nitrile Examination Gloves (Model:XYS-001)Anhui Xinyisheng Medical Technology Co.,Ltd · 2021

All 2 as Anhui Xinyisheng Medical Technology Co.,Ltd →