FDA applicant

Tangshan Kaiyue Glove Co., Ltd.

Haidian Dis, Beijing, CN1 decision2011–20111 recall

FDA records 1 decision for Tangshan Kaiyue Glove Co., Ltd. (Haidian Dis, Beijing, CN) in 2011: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 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 Kaiyue Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2016

2011high 1 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Tangshan Kaiyue Glove Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tangshan Kaiyue 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 Kaiyue 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”