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Sign in to claim this brandUltragard
US
Last updated May 30, 2026
What Ultragard makes
Ultragard manufactures single-use examination and treatment gloves made from nitrile, hevea latex, and vinyl. The gloves are produced in non-powdered and non-antimicrobial variants, designed for medical and clinical settings to reduce contamination risk during procedures. These products are intended for general use in healthcare environments, including surgical and diagnostic applications.
The company’s glove portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. These products are regulated under the US Food and Drug Administration’s requirements for general medical gloves, ensuring compliance with safety and performance standards for single-use barriers in healthcare.
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 Ultragard manufacture?
Ultragard specializes in single-use examination and treatment gloves, offering three primary materials: nitrile, hevea latex, and vinyl. All variants are produced in non-powdered and non-antimicrobial forms. These gloves are designed for medical and clinical use to minimize contamination risks during procedures, including surgical and diagnostic applications.
Where is Ultragard based, and how does that affect its regulatory compliance?
Ultragard is based in the United States, which means its devices are subject to FDA regulations. Since its gloves fall under Class I medical devices, they are regulated under the FDA’s general controls for low-risk devices, ensuring compliance with safety and performance standards for single-use barriers in healthcare settings.
Are Ultragard’s devices listed in any regulatory registries, and why does this matter?
Yes, Ultragard’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps healthcare providers, regulators, and supply chain partners verify the identity of medical devices, ensuring traceability and reducing risks associated with counterfeit or mislabeled products.
How are Ultragard’s gloves classified by the FDA, and what does that classification mean?
Ultragard’s gloves are classified as Class I medical devices by the FDA. This classification is assigned to devices posing minimal potential risk to patients, such as single-use gloves. Class I devices typically require general controls like good manufacturing practices (GMP) and labeling requirements, but they do not undergo premarket approval or postmarket surveillance beyond standard compliance checks.
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
- 175840941
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultragard | BB5000-L | FDA UDI | Class I | Active |
| Ultragard | UGPF-S | FDA UDI | Class I | Active |
| Ultragard | V300-M | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-XXL | FDA UDI | Class I | Active |
| Ultragard | V300-S | FDA UDI | Class I | Active |
| Ultragard | N300-XL | FDA UDI | Class I | Active |
| Ultragard | N300-M | FDA UDI | Class I | Active |
| Ultragard | UGNTPF-XL | FDA UDI | Class I | Active |
| Ultragard | UGET-XXL | FDA UDI | Class I | Active |
| Ultragard | BB5000-XXL | FDA UDI | Class I | Active |
| Ultragard | N350-XL | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-M | FDA UDI | Class I | Active |
| Ultragard | N350-S | FDA UDI | Class I | Active |
| Ultragard | N300-XS | FDA UDI | Class I | Active |
| Ultragard | UGET-L | FDA UDI | Class I | Active |
| Ultragard | L300-M | FDA UDI | Class I | Active |
| Ultragard | N300-XXL | FDA UDI | Class I | Active |
| Ultragard | N350-XS | FDA UDI | Class I | Active |
| Ultragard | UGNTPF-L | FDA UDI | Class I | Active |
| Ultragard | L300-L | FDA UDI | Class I | Active |
| Ultragard | BB5000-S | FDA UDI | Class I | Active |
| Ultragard | UGNTPF-S | FDA UDI | Class I | Active |
| Ultragard | UGPF-M | FDA UDI | Class I | Active |
| Ultragard | UGNTPF-M | FDA UDI | Class I | Active |
| Ultragard | L300-S | FDA UDI | Class I | Active |
| Ultragard | L300-XL | FDA UDI | Class I | Active |
| Ultragard | UGET-S | FDA UDI | Class I | Active |
| Ultragard | BB5000-M | FDA UDI | Class I | Active |
| Ultragard | V300-L | FDA UDI | Class I | Active |
| Ultragard | N300-L | FDA UDI | Class I | Active |
| Ultragard | UGPF-XL | FDA UDI | Class I | Active |
| Ultragard | B300-L | FDA UDI | Class I | Active |
| Ultragard | V300-XL | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-XL | FDA UDI | Class I | Active |
| Ultragard | UGNTPF-XS | FDA UDI | Class I | Active |
| Ultragard | BB5000-XL | FDA UDI | Class I | Active |
| Ultragard | B300-M | FDA UDI | Class I | Active |
| Ultragard | B300-S | FDA UDI | Class I | Active |
| Ultragard | UGET-XL | FDA UDI | Class I | Active |
| Ultragard | UGPF-L | FDA UDI | Class I | Active |
| Ultragard | L300-XS | FDA UDI | Class I | Active |
| Ultragard | N350-M | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-L | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-XXXL | FDA UDI | Class I | Active |
| Ultragard | B300-XL | FDA UDI | Class I | Active |
| Ultragard | UGNT8PF-S | FDA UDI | Class I | Active |
| Ultragard | N300-S | FDA UDI | Class I | Active |
| Ultragard | N350-L | FDA UDI | Class I | Active |
| Ultragard | UGET-M | FDA UDI | Class I | Active |
| Ultragard | UGPF-XS | FDA UDI | Class I | Active |
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