510(k) Report

FDA applicant

Han Zhaoqing Sporting Goods Company Limited

Zhaoqing, CN2 decisions2021–20210 recalls

FDA records 2 decisions for Han Zhaoqing Sporting Goods Company Limited (Zhaoqing, CN) in 2021: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). 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 Han Zhaoqing Sporting Goods Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2021: 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Han Zhaoqing Sporting Goods Company Limited 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

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?

  • K202316Medical mask (Model: KKF-1A)Han Zhaoqing Sporting Goods Company Limited · 2021
  • K202314Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited · 2021

All 2 as Han Zhaoqing Sporting Goods Company Limited →