FDA applicant
Hainan Asther Medical Equipment Co., Ltd.
FDA records 1 decision for Hainan Asther Medical Equipment Co., Ltd. (Chengmai, CN) in 2022: 1 510(k) clearance. All are in product code LZC (Medical Glove, Specialty). 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 Hainan Asther Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Hainan Asther Medical Equipment Co.…’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