FDA applicant
Hunan Zhenheyikang Medical Instrument Co., Ltd.
FDA records 2 decisions for Hunan Zhenheyikang Medical Instrument Co., Ltd. (Xiangtan, CN) in 2022: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) 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 Hunan Zhenheyikang Medical Instrument 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 2022.
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