FDA applicant
Jiangsu Nanfang Medical Co., Ltd.
FDA records 2 decisions for Jiangsu Nanfang Medical Co., Ltd. (Changzhou, CN) from 2021 to 2022: 2 510(k) clearances. Most are in product codes LZC (Medical Glove, Specialty) and FXX (Mask, Surgical). Its devices cite 2 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 Jiangsu Nanfang Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Jiangsu Nanfang Medical 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