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Sign in to claim this brandLingshi Hongruida Health Protection Technology Co., Ltd.
US
Last updated May 25, 2026
What Lingshi Hongruida Health Protection Technology 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 products fall under FDA Class I regulatory classification and are listed via 510(k) and UDI registrations 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 Lingshi Hongruida Health Protection Technology Co., Ltd. manufacture?
Lingshi Hongruida Health Protection Technology Co., Ltd. specializes in producing nitrile examination and treatment gloves. These gloves are designed for medical and clinical use and are specifically non-powdered and non-antimicrobial, ensuring they meet common hygiene and safety standards in healthcare settings.
Where is Lingshi Hongruida Health Protection Technology Co., Ltd. based?
The company is based in the United States. While the exact location isn’t specified, its regulatory filings and listings, such as FDA submissions, confirm its operational presence and compliance activities within the country.
Which regulatory registries or databases list the devices manufactured by Lingshi Hongruida Health Protection Technology Co., Ltd.?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class I devices like nitrile gloves, which require such documentation for market authorization in the U.S.
How are the devices produced by Lingshi Hongruida Health Protection Technology Co., Ltd. classified under regulatory standards?
The company’s nitrile examination and treatment gloves fall under FDA Class I regulatory classification. This classification applies to low-risk medical devices where general controls (like good manufacturing practices) are sufficient for ensuring safety and effectiveness, though specific devices may still require premarket submissions like 510(k)s for market authorization.
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
- 601474873
Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hongray | L | FDA UDI | Class I | Active |
| Hongray | XXL | FDA UDI | Class I | Active |
| Hongray | S | FDA UDI | Class I | Active |
| Hongray | S | FDA UDI | Class I | Active |
| Hongray | XXL | FDA UDI | Class I | Active |
| Hongray | L | FDA UDI | Class I | Active |
| Hongray | XS | FDA UDI | Class I | Active |
| Hongray | XL | FDA UDI | Class I | Active |
| Hongray | L | FDA UDI | Class I | Active |
| Hongray | XS | FDA UDI | Class I | Active |
| Hongray | XL | FDA UDI | Class I | Active |
| Hongray | XL | FDA UDI | Class I | Active |
| Hongray | S | FDA UDI | Class I | Active |
| Hongray | M | FDA UDI | Class I | Active |
| Hongray | M | FDA UDI | Class I | Active |
| Hongray | L | FDA UDI | Class I | Active |
| Hongray | XS | FDA UDI | Class I | Active |
| Hongray | M | FDA UDI | Class I | Active |
| Hongray | XL | FDA UDI | Class I | Active |
| Hongray | XXL | FDA UDI | Class I | Active |
| Hongray | S | FDA UDI | Class I | Active |
| Hongray | XS | FDA UDI | Class I | Active |
| Hongray | XXL | FDA UDI | Class I | Active |
| Hongray | M | FDA UDI | Class I | Active |
| Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | K223320 | FDA 510(k) | Class I | Active |
| Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | K243959 | FDA 510(k) | Class I | Active |
| Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | K240051 | 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.
- Lingshi Hongruida Health Protection Technology Co., Ltd. Jinzhong City Shanxi · CN FEI 3020984755