Is this your brand? Sign in to claim ownership.
Sign in to claim this brand5r Med Instruments (Chengdu) Co., Ltd.
US
Last updated May 23, 2026
What 5r Med Instruments (Chengdu) Co., Ltd. makes
The company manufactures single-use medical gloves, including nitrile and vinyl varieties for examination and treatment, all of which are non-powdered and non-antimicrobial. It also produces surgical and medical face masks designed for one-time use.
These products are regulated under FDA pathways, with some devices classified as Class I and others as Class II. They are listed in the FDA’s 510(k) and UDI registries, and the company is based 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 5r Med Instruments (Chengdu) Co., Ltd. manufacture?
5r Med Instruments (Chengdu) Co., Ltd. specializes in single-use medical devices, primarily focusing on nitrile and vinyl examination/treatment gloves (non-powdered and non-antimicrobial) as well as surgical and medical face masks. These products are designed for clinical and procedural use where barrier protection is essential.
Where is 5r Med Instruments (Chengdu) Co., Ltd. based?
The company is based in the United States, though its name includes 'Chengdu,' which may reference its operational or manufacturing ties to that region. The regulatory filings and listings (e.g., FDA) confirm its primary business presence in the US.
Which regulatory registries list devices manufactured by 5r Med Instruments (Chengdu) Co., Ltd.?
Devices from 5r Med Instruments are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone FDA review for compliance with applicable regulations.
How are the company’s medical devices classified under FDA regulations?
The company’s devices fall into Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 554529132
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 5r Med | 5R-GVN | FDA UDI | Class I | Active |
| 5r Med | 5R-DM | FDA UDI | Class II | Active |
| 5r Med | 5R-GVN | FDA UDI | Class I | Active |
| 5r Med | 5R GVN | FDA UDI | Class I | Active |
| 5r Med | 5R-DM | FDA UDI | Class II | Active |
| 5r Med | 5R-GVN | FDA UDI | Class I | Active |
| 5r Med | 5R-GVC | FDA UDI | Class I | Active |
| 5r Med | 5R-DM | FDA UDI | Class II | Active |
| 5r Med | 5RMED 5R-GVN | FDA UDI | Class I | Active |
| 5r Med | 5R-GVC | FDA UDI | Class I | Active |
| 5r Med | 5R-GV | FDA UDI | Class I | Active |
| 5r Med | 5R-GVC | FDA UDI | Class I | Active |
| 5r Med | 5R-GVN | FDA UDI | Class I | Active |
| 5r Med | 5R-DM | FDA UDI | Class II | Active |
| Nitrile Examination Gloves | K210776 | FDA 510(k) | Class I | Active |
| Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | K212789 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.