Is this your brand? Sign in to claim ownership.
Sign in to claim this brandJiangxi Hongda Medical Equipment Group Co., Ltd.
US
Last updated May 23, 2026
What Jiangxi Hongda Medical Equipment Group Co., Ltd. makes
The company manufactures non-powdered, non-antimicrobial nitrile examination gloves for medical use, including blue, powder-free variants, as well as single-use medical face masks and sterile, disposable syringes with attached needles.
These products are regulated under FDA classifications, including Class I and Class II devices, and are listed in the FDA’s 510(k) and UDI registries. 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 Jiangxi Hongda Medical Equipment Group Co., Ltd. manufacture?
Jiangxi Hongda Medical Equipment Group Co., Ltd. primarily manufactures nitrile examination gloves (non-powdered, non-antimicrobial), including blue, powder-free variants, as well as single-use medical face masks and sterile, single-use syringes with attached needles. These devices are designed for medical examination, treatment, and procedural use.
Where is Jiangxi Hongda Medical Equipment Group Co., Ltd. based?
The company operates in the United States, though its name suggests origins in Jiangxi, China. Its products are regulated under U.S. FDA guidelines, including classification and registration requirements.
Which regulatory registries list Jiangxi Hongda Medical Equipment Group Co., Ltd.'s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification registry (for Class II devices requiring clearance) and the FDA’s Unique Device Identifier (UDI) database (for traceability and identification). These registries ensure compliance with U.S. medical device regulations.
How are Jiangxi Hongda Medical Equipment Group Co., Ltd.'s devices classified under FDA regulations?
The company’s devices fall into Class I (generally low-risk, such as some gloves and syringes) and Class II (moderate-risk, like certain examination gloves or syringes with specific features) under FDA classification. Class II devices typically require premarket submission (e.g., 510(k)), while Class I devices may only need registration and listing.
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
- —
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medical Nitrile Examination Gloves (Power free, Blue) | XS | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | M | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | L | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | XL | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | M | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | XL | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | XS | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | S | FDA UDI | Class I | Active |
| Sterile Single-use Syringe with Needle | 5mL LL 23G×1 1/4" (0.6mm×32mm) | FDA UDI | Class II | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | L | FDA UDI | Class I | Active |
| Medical Nitrile Examination Gloves (Power free, Blue) | S | FDA UDI | Class I | Active |
| Single-Use Medical Face Mask | K210622 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.