FDA applicant

Zhejiang Hangkang Medical Equipment Co., Ltd.

Yiwu, CN1 decision2026–20260 recalls

FDA records 1 decision for Zhejiang Hangkang Medical Equipment Co., Ltd. (Yiwu, CN) in 2026: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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 Zhejiang Hangkang Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Zhejiang Hangkang Medical Equipment Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?