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Sign in to claim this brandHengchang (Dongying) Medical Technology Co., Ltd.
US
Last updated May 23, 2026
What Hengchang (Dongying) Medical Technology Co., Ltd. makes
Hengchang (Dongying) Medical Technology Co., Ltd. manufactures nitrile exam gloves, including powder-free blue variants tested for use with chemotherapy and standard powder-free blue gloves.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Hengchang (Dongying) Medical Technology Co., Ltd. manufacture?
Hengchang (Dongying) Medical Technology Co., Ltd. specializes in manufacturing nitrile exam gloves. These include powder-free blue gloves and a specific variant tested for use with chemotherapy, ensuring compatibility with sensitive procedures.
Where is Hengchang (Dongying) Medical Technology Co., Ltd. based?
The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs its device listings and compliance requirements.
Which regulatory registries list Hengchang’s medical devices?
Hengchang’s nitrile exam gloves are listed under the FDA’s 510(k) pathway. This pathway is used for Class I devices that are not low-risk but require demonstration of substantial equivalence to a predicate device.
How are Hengchang’s devices classified under medical device regulations?
Hengchang’s nitrile exam gloves fall under Class I classification. This classification is assigned to devices posing minimal risk to users, such as single-use gloves, which typically require less stringent regulatory oversight than higher-risk devices.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Henchan | HCMUXXX | FDA UDI | Class I | Active |
| Nitrile Exam Gloves, Powder Free, Blue (Tested for Use with Chemotherapy) | K211714 | FDA 510(k) | Class I | Active |
| Nitrile Exam Gloves, Powder Free, Blue | K211699 | FDA 510(k) | Class I | Active |
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