FDA applicant
Wuhan Zonsen Medical Products Co., Ltd.
FDA records 6 decisions for Wuhan Zonsen Medical Products Co., Ltd. (Wuhan, CN) from 2021 to 2023: 6 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 206 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 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
How often FDA has decided Wuhan Zonsen Medical Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Wuhan Zonsen Medical Products 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