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Hunan Zhenheyikang Medical Instrument Co., Ltd.

ChinaFDA applicant, unverified

Devices
2

What Hunan Zhenheyikang Medical Instrument Co., Ltd. makes

Hunan Zhenheyikang Medical Instrument Co., Ltd. manufactures medical nitrile examination gloves and surgical masks, designed for single-use in clinical and procedural settings to maintain hygiene and barrier protection.

These products are regulated under FDA 510(k) clearance requirements, with devices classified as Class I and Class II. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Medical Nitrile Examination Gloves Ref K220066

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Medical Surgical Mask Ref K213724

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Hunan Zhenheyikang Medical Instrument Co., Ltd. have in the registry?

The registry currently lists 2 devices for Hunan Zhenheyikang Medical Instrument Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hunan Zhenheyikang Medical Instrument Co., Ltd.'s devices?

Among its 2 most recently registered devices, Hunan Zhenheyikang Medical Instrument Co., Ltd. has devices listed in FDA 510(k) (2 devices).

What risk classes do Hunan Zhenheyikang Medical Instrument Co., Ltd.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Hunan Zhenheyikang Medical Instrument Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hunan Zhenheyikang Medical Instrument Co., Ltd. in the registry?

The most recently registered devices listed for Hunan Zhenheyikang Medical Instrument Co., Ltd. include Medical Nitrile Examination Gloves and Medical Surgical Mask.

Generated automatically from registry data and not verified by a human reviewer.