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Sign in to claim this brandWeihai Hongyu Nonwoven Fabric Products Co., Ltd.
US
Last updated May 31, 2026
What Weihai Hongyu Nonwoven Fabric Products Co., Ltd. makes
The company manufactures single-use medical textiles, including disposable surgical gowns, sterilization wraps, surgical drapes, surgical masks, and powder-free nitrile examination gloves.
These products are regulated under FDA Class I and Class II categories, with some devices listed via 510(k) and UDI registrations. The company operates 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. manufacture?
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. specializes in single-use medical textiles. Their primary products include disposable surgical gowns, sterilization wraps, surgical drapes, surgical masks, and powder-free nitrile examination gloves. These items are designed for one-time use in clinical settings to ensure hygiene and infection control.
Where is Weihai Hongyu Nonwoven Fabric Products Co., Ltd. based?
The company operates in the United States. While the name suggests a Chinese origin, their listed devices and regulatory presence are tied to the US market, where they contribute to medical textiles used in healthcare settings.
Which regulatory registries list Weihai Hongyu Nonwoven Fabric Products Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US medical device regulations, particularly for products like surgical gowns and gloves, which fall under Class I and Class II classifications.
How are Weihai Hongyu Nonwoven Fabric Products Co., Ltd.’s medical devices classified under FDA regulations?
The company’s devices are classified under FDA’s Class I (general controls) and Class II (special controls) categories. Class I includes lower-risk items like some surgical drapes, while Class II applies to higher-risk products like surgical gowns and gloves, which require additional regulatory oversight to ensure safety and effectiveness.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 421260215
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Surgical Gowns | SUM201022-XL | FDA UDI | Class II | Active |
| Disposable Surgical Gowns | SUM201022-L | FDA UDI | Class II | Active |
| Disposable Surgical Gown | K214088 | FDA 510(k) | Class II | Active |
| Sterilization Wraps | K220133 | FDA 510(k) | Class II | Active |
| Disposable Surgical Gowns | K120192 | FDA 510(k) | Class II | Active |
| Surgical Masks | K212807 | FDA 510(k) | Class II | Active |
| Hongyu Disposable Surgical Drapes | K141324 | FDA 510(k) | Class II | Active |
| Nitrile Examination Gloves (Powder free, Blue) | K213029 | FDA 510(k) | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd Weihai Shandong · CN FEI 3008489813