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Sign in to claim this brandSHANGHAI MOTEX HEALTHCARE CO., LTD.
China·CN-MF-000016264
Last updated September 17, 2026
What SHANGHAI MOTEX HEALTHCARE CO., LTD. makes
Shanghai Motex Healthcare produces single-use surgical and examination gloves made from nitrile, latex, and polyisoprene materials, including powder-free and lightly powdered variants for medical and procedural use.
The company’s products are classified as Class I medical devices and are listed in the FDA’s 510(k) registry. The manufacturer is based in China.
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 Shanghai Motex Healthcare Co., Ltd. manufacture?
Shanghai Motex Healthcare Co., Ltd. specializes in single-use medical gloves for surgical and examination purposes. Their product line includes gloves made from nitrile, latex, and polyisoprene, available in powder-free and lightly powdered versions. These gloves are designed for medical and procedural use to maintain sterility and reduce contamination risks.
Where is Shanghai Motex Healthcare Co., Ltd. based?
The company is headquartered in China. This geographic location influences its regulatory compliance and market reach, particularly for devices intended for global distribution.
Which regulatory registries list Shanghai Motex Healthcare Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) registry. This classification indicates that their products have undergone a premarket notification process, demonstrating compliance with U.S. regulatory standards for Class I devices.
How are Shanghai Motex Healthcare Co., Ltd.’s devices classified under medical device regulations?
The company’s products are classified as Class I medical devices. This classification applies to low-risk items like single-use gloves, where general controls (such as good manufacturing practices) are sufficient for ensuring safety and effectiveness. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- No. 369, Jiasong Zhong Rd., Huaxin, Qingpu, Shanghai, China
- Website
- www.shmotex.com
- —
- —
- [email protected]
- Phone
- +86 21 59799888
- PRRC Contact
- Stephy Liu
- EUDAMED SRN
- CN-MF-000016264
- FDA FEI Number
- 3003045222
- DUNS Number
- —
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Motex Latex Examination Gloves, Powder-Free | K020837 | FDA 510(k) | Class I | Active |
| Motex Powder-Free Nitrile Surgical Gloves | K122557 | FDA 510(k) | Class I | Active |
| Motex Powdered Nitrile Surgical Gloves | K132802 | FDA 510(k) | Class I | Active |
| Motex Powder-Free Surgical Gloves And Lightly Powdered Surgical Gloves | K063757 | FDA 510(k) | Class I | Active |
| Motex Nitrile Examination Gloves Powder-Free | K013261 | FDA 510(k) | Class I | Active |
| Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) And # 6512(6532) | K123126 | FDA 510(k) | Class I | Active |
| Nitrile Powder-Free Examination Gloves, Problue, #7235 7 #7735 | K030207 | FDA 510(k) | Class I | Active |
| Powder-Free Nitrile Examination Gloves | K041276 | EUDAMEDFDA 510(k) | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shanghai Motex Healthcare Co., Ltd. US