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Sign in to claim this brandPRIME SOLUTIONS, INC.
US
Last updated May 23, 2026
What PRIME SOLUTIONS, INC. makes
Prime Solutions, Inc. manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial. Their portfolio includes products like the DERMATOUCH and CAP'N K, designed for medical and clinical use.
These devices are classified under Class I in the US regulatory framework 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 Prime Solutions, Inc. manufacture?
Prime Solutions, Inc. specializes in manufacturing nitrile examination and treatment gloves. These gloves are designed for medical and clinical use, specifically as non-powdered and non-antimicrobial products. Examples of their devices include the DERMATOUCH and CAP'N K, which are tailored for protective and procedural applications in healthcare settings.
Where is Prime Solutions, Inc. based?
Prime Solutions, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available data.
Which regulatory registries list Prime Solutions, Inc.’s devices?
Prime Solutions, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the United States, ensuring traceability and compliance with regulatory requirements. The inclusion in this database reflects the devices’ classification and regulatory status.
How are Prime Solutions, Inc.’s devices classified under US regulations?
Prime Solutions, Inc.’s devices, such as the DERMATOUCH and CAP'N K, fall under Class I classification in the US regulatory framework. This classification is typically assigned to low-risk medical devices that pose minimal potential harm to users. The classification determines the regulatory pathway and oversight required for these products.
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
- 093300590
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dermatouch | 81250MD/M | FDA UDI | Class I | Active |
| Cap'n K | MWSPN/M | FDA UDI | Class I | Active |
| Cap'n K | MWSPN/XL | FDA UDI | Class I | Active |
| Cap'n K | MWSPN/2XL | FDA UDI | Class I | Active |
| Dermatouch | 81250MD/L | FDA UDI | Class I | Active |
| Dermatouch | 81135/M | FDA UDI | Class I | Active |
| Cap'n K | MWSPN/S | FDA UDI | Class I | Active |
| Cap'n K | MWSPN/L | FDA UDI | Class I | Active |
| Dermatouch | 81135/XS | FDA UDI | Class I | Active |
| Dermatouch | 81135/XL | FDA UDI | Class I | Active |
| Dermatouch | 81135/L | FDA UDI | Class I | Active |
| Dermatouch | 81135/2XL | FDA UDI | Class I | Active |
| Dermatouch | 81250MD/XL | FDA UDI | Class I | Active |
| Dermatouch | 81135/S | FDA UDI | Class I | Active |
| Dermatouch | 81250MD/S | FDA UDI | Class I | Active |
| Dermatouch | 81250MD/2XL | FDA UDI | Class I | Active |
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