510(k) Report

FDA applicant

Hubei Wanli Protective Products Co., Ltd.

Xiantao, CN3 decisions2021–20220 recalls

FDA records 3 decisions for Hubei Wanli Protective Products Co., Ltd. (Xiantao, CN) from 2021 to 2022: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Hubei Wanli Protective Products 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 — Hubei Wanli Protective Products 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?

  • FXXMask, Surgical2decisions
  • FYAGown, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 162 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K210150Disposable Medical maskHubei Wanli Protective Products Co., Ltd. · 20211cites it
  • K211509Surgical GownHubei Wanli Protective Products Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K214085Disposable Medical MaskHubei Wanli Protective Products Co., Ltd. · 2022
  • K211509Surgical GownHubei Wanli Protective Products Co., Ltd. · 2021
  • K210150Disposable Medical maskHubei Wanli Protective Products Co., Ltd. · 2021

All 3 as Hubei Wanli Protective Products Co., Ltd. →