FDA applicant
Niujian Technology Co., Ltd.
FDA records 3 decisions for Niujian Technology Co., Ltd. (Shaoxing, CN) from 2021 to 2022: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 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 Niujian Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Niujian Technology 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