FDA applicant

Zibo Chengxun Automatic Device Co., Ltd.

Zibo, CN1 decision2017–20170 recalls

FDA records 1 decision for Zibo Chengxun Automatic Device Co., Ltd. (Zibo, CN) in 2017: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). 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 Zibo Chengxun Automatic Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Zibo Chengxun Automatic Device Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zibo Chengxun Automatic Device 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 “Zibo”

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

Zibo Sinocare Plastic Products Co., Ltd. 4 Zibo Intco Medical Products Co., Ltd. 3 Zibo Yinghao Medical Products Co., Ltd. 3 Zibo Zhuangyuan Plastic & Rubber Co., Ltd. 2 Zibo Goldenline Plastic Product Co., Ltd. 2 Zibo Borui Plastic & Rubber Products Co., Ltd. 2 Zibo Hengde Plastic & Rubber Products Co., Ltd. 2 Zibo Blue Sail Plastic & Rubber Products Co., Ltd. 2 Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. 2 Zibo Blue Intco Plastic & Rubber Products Co., Ltd. 2 Zibo Hengchang Plastic & Rubber Products Co., Ltd. 2 Zibo Yusheng Plastic Products Co., Ltd. 2

Zibo Chengxun Automatic Device Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Zibo”