FDA applicant

Tangshan Huamei Healthcare Co., Ltd.

Haidian Dis, Beijing, CN1 decision2009–20090 recalls

FDA records 1 decision for Tangshan Huamei Healthcare Co., Ltd. (Haidian Dis, Beijing, CN) in 2009: 1 510(k) clearance. All are in product code LYZ (Vinyl 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 Tangshan Huamei Healthcare Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Tangshan Huamei Healthcare Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tangshan Huamei Healthcare Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Tangshan”

FDA records each applicant name separately; these may or may not be the same firm.

Tangshan Huamei Healthcare Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Tangshan”