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Sign in to claim this brandShanghai Motex Healthcare Co., Ltd.
US
Last updated May 27, 2026
What Shanghai Motex Healthcare Co., Ltd. makes
The company manufactures single-use surgical and examination gloves, including non-powdered nitrile, latex-free polyisoprene (with antimicrobial properties), and non-powdered latex alternatives. These products are designed for medical, dental, and clinical procedures to provide barrier protection against pathogens and contaminants. Powdered nitrile examination gloves are also part of the portfolio for specific procedural needs. The gloves are intended for one-time use and comply with standards for patient and user safety in sterile environments.
All listed devices fall under Class I regulatory classification, indicating low-to-moderate risk and subject to general controls. The products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States, adhering to applicable domestic and international standards for sterile barrier devices.
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 gloves for medical, dental, and clinical settings. Their portfolio includes non-powdered nitrile surgical gloves, latex-free polyisoprene gloves (with antimicrobial properties), non-powdered latex alternatives, and nitrile examination/treatment gloves, both powdered and non-powdered. These products are designed to provide barrier protection during procedures, ensuring safety for both patients and users.
Where is Shanghai Motex Healthcare Co., Ltd. based, and how does that affect its products?
The company is based in the United States, which means its products comply with U.S. medical device regulations, including registration in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to domestic standards for sterile barrier devices like gloves, which are critical in healthcare environments.
Which regulatory registries list the devices made by Shanghai Motex Healthcare Co., Ltd.?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a central registry for tracking medical devices in the U.S. This database helps ensure transparency, traceability, and compliance with regulatory requirements for low-to-moderate risk products like gloves, which fall under Class I classification.
How are the gloves manufactured by Shanghai Motex Healthcare Co., Ltd. classified under medical device regulations?
All gloves produced by Shanghai Motex Healthcare Co., Ltd. are classified as Class I devices under U.S. regulations. This classification applies to products with low-to-moderate risk, meaning they are subject to general controls (such as manufacturing practices, labeling, and registration) rather than stringent pre-market approvals. The focus is on ensuring basic safety and performance for single-use barrier protection.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- 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
- 530438738
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MocareHealth | 6512WH60B | FDA UDI | Class I | Active |
| MocareHealth | 723565 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST85 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH55B | FDA UDI | Class I | Active |
| MocareHealth | 181065 | FDA UDI | Class I | Active |
| MocareHealth | 723570 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST55 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH80B | FDA UDI | Class I | Active |
| MocareHealth | 6610GN75 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH90B | FDA UDI | Class I | Active |
| MocareHealth | 6610GN55B | FDA UDI | Class I | Active |
| MocareHealth | 171065 | FDA UDI | Class I | Active |
| MocareHealth | 181075 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST90 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN60B | FDA UDI | Class I | Active |
| MocareHealth | 6610GN80B | FDA UDI | Class I | Active |
| MocareHealth | 181070 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN80 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN90B | FDA UDI | Class I | Active |
| MocareHealth | 6610GN65B | FDA UDI | Class I | Active |
| MocareHealth | 1610ST70 | FDA UDI | Class I | Active |
| MocareHealth | 181080 | FDA UDI | Class I | Active |
| MocareHealth | 171080 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST75 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH70B | FDA UDI | Class I | Active |
| MocareHealth | 6610GN60 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH65B | FDA UDI | Class I | Active |
| MocareHealth | 6512WH75B | FDA UDI | Class I | Active |
| MocareHealth | 723575 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN70B | FDA UDI | Class I | Active |
| MocareHealth | 6512WH65 | FDA UDI | Class I | Active |
| MocareHealth | 171070 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST65 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN75B | FDA UDI | Class I | Active |
| MocareHealth | 6512WH85B | FDA UDI | Class I | Active |
| MocareHealth | 181060 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN70 | FDA UDI | Class I | Active |
| MocareHealth | 723575 | FDA UDI | Class I | Active |
| MocareHealth | 723560 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN65 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH70 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST60 | FDA UDI | Class I | Active |
| MocareHealth | 723580 | FDA UDI | Class I | Active |
| MocareHealth | 1610ST80 | FDA UDI | Class I | Active |
| MocareHealth | 6610GN85B | FDA UDI | Class I | Active |
| MocareHealth | 6512WH80 | FDA UDI | Class I | Active |
| MocareHealth | 171060 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH60 | FDA UDI | Class I | Active |
| MocareHealth | 6512WH75 | FDA UDI | Class I | Active |
| MocareHealth | 171075 | FDA UDI | Class I | Active |
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