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Sign in to claim this brandEmpire Managed Solutions LLC
US
Last updated May 25, 2026
What Empire Managed Solutions LLC makes
Empire Managed Solutions LLC produces nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, designed for medical and procedural use.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 Empire Managed Solutions LLC manufacture?
Empire Managed Solutions LLC specializes in producing nitrile examination and treatment gloves. These gloves are designed for medical and procedural use and are specifically formulated as non-powdered and non-antimicrobial, ensuring they meet common clinical requirements for safety and usability.
Where is Empire Managed Solutions LLC based?
Empire Managed Solutions LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction for device authorization.
How are the devices manufactured by Empire Managed Solutions LLC classified under FDA regulations?
The nitrile examination and treatment gloves produced by Empire Managed Solutions LLC fall under Class I classification according to FDA regulations. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and effectiveness, reducing the need for additional pre-market review.
Are the devices from Empire Managed Solutions LLC listed in any regulatory databases?
Yes, the devices manufactured by Empire Managed Solutions LLC are included in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.
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
- 117334642
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Empire | 5.5 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 4 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
| Empire | 4 MIL Nitrile Gloves- Case | FDA UDI | Class I | Active |
| Empire | 5 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
| Empire | 4 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
| Empire | 5.5 MIL Nitrile Gloves- Box | FDA UDI | Class I | Active |
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