510(k) Report

FDA applicant

Changzhou Universal Medical Equipment Co., Ltd.

Changzhou, CN3 decisions2021–20220 recalls

FDA records 3 decisions for Changzhou Universal Medical Equipment Co., Ltd. (Changzhou, CN) from 2021 to 2022: 3 510(k) clearances. Most are in product codes LAZ (N-Acetylprocainamide Control Materials) and LZA (Polymer 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 hospital panel, where it files most

How often FDA has decided Changzhou Universal Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 22022: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Changzhou Universal Medical Equipment…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LAZN-Acetylprocainamide Control Materials1decision
  • LZAPolymer Patient Examination Glove1decision
  • LZCMedical Glove, Specialty1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210145Nitrile Glove Powder Free BlueChangzhou Universal Medical Equipment Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsChangzhou Universal Medical Equipment Co., Ltd. · 2022
  • K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
  • K210145Nitrile Glove Powder Free BlueChangzhou Universal Medical Equipment Co., Ltd. · 2021

All 3 as Changzhou Universal Medical Equipment Co., Ltd. →