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Sign in to claim this brandZhenjiang Suhui Latex Products Co., Ltd.
US
Last updated May 24, 2026
What Zhenjiang Suhui Latex Products Co., Ltd. makes
The company manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, designed for medical and clinical use.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. The company is based in the US.
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 Zhenjiang Suhui Latex Products Co., Ltd. manufacture?
Zhenjiang Suhui Latex Products Co., Ltd. specializes in manufacturing nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. These gloves are designed for medical and clinical use, ensuring protection and hygiene in healthcare settings.
Where is Zhenjiang Suhui Latex Products Co., Ltd. based?
The company is based in the United States. This location allows it to comply with regulatory standards and requirements applicable to medical devices in the US market.
Which regulatory registries list the devices manufactured by Zhenjiang Suhui Latex Products Co., Ltd.?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries help track and identify medical devices for regulatory and market surveillance purposes.
How are the devices produced by Zhenjiang Suhui Latex Products Co., Ltd. classified under FDA regulations?
The nitrile examination and treatment gloves manufactured by the company fall under Class I classification according to FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, allowing for streamlined regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 530808336
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Suhui | Nitrile | FDA UDI | Class I | Active |
| Nitrile Examination Gloves, Green/ Blue/ Black Color | K211778 | FDA 510(k) | Class I | Active |
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