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Sign in to claim this brandTianjin Aoshang Outdoor Equipment Co., Ltd.
US
Last updated May 25, 2026
What Tianjin Aoshang Outdoor Equipment Co., Ltd. makes
The company produces single-use surgical/medical face masks and aerosol face masks designed for non-rebreathing applications. It also manufactures nitrile exam gloves for medical examinations.
These products are regulated as Class I and Class II devices under FDA requirements, with some listed via the 510(k) and UDI pathways. 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 Tianjin Aoshang Outdoor Equipment Co., Ltd. manufacture?
Tianjin Aoshang Outdoor Equipment Co., Ltd. primarily manufactures single-use surgical/medical face masks and aerosol face masks designed for non-rebreathing applications. Additionally, they produce nitrile exam gloves, which are used for medical examinations. These products are intended for healthcare settings to ensure hygiene and protection.
Where is Tianjin Aoshang Outdoor Equipment Co., Ltd. based?
The company is based in the United States. While the name suggests a location in China, the operational headquarters or primary manufacturing presence for regulatory purposes is in the US.
Which regulatory registries or databases list the devices manufactured by Tianjin Aoshang Outdoor Equipment Co., Ltd.?
The company’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These pathways are used to track and classify medical devices under FDA regulations, ensuring compliance and traceability.
How are the devices produced by Tianjin Aoshang Outdoor Equipment Co., Ltd. classified under FDA regulations?
The devices manufactured by Tianjin Aoshang Outdoor Equipment Co., Ltd. are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
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
- 554530356
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aoshang | earloop | FDA UDI | Class II | Active |
| Aoshang | earloop | FDA UDI | Class II | Active |
| Aoshang | earloop | FDA UDI | Class II | Active |
| Aoshang | earloop | FDA UDI | Class II | Unknown |
| Aoshang | earloop | FDA UDI | Class II | Active |
| Aoshang | earloop | FDA UDI | Class II | Active |
| Medical Surgical Mask | K210030 | FDA 510(k) | Class II | Active |
| Synguard Nitrile Exam Glove | K220442 | FDA 510(k) | Class I | Active |
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