FDA applicant

Tangshan Kangyuan Glove Co., Ltd.

Beijing, CN3 decisions2009–20101 recall

FDA records 3 decisions for Tangshan Kangyuan Glove Co., Ltd. (Beijing, CN) from 2009 to 2010: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Kangyuan Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2018

2009high 1 (2018) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Tangshan Kangyuan Glove 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 Kangyuan Glove Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Tangshan”