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Sign in to claim this brandToptolife, LLC
US
Last updated May 25, 2026
What Toptolife, LLC makes
Toptolife, LLC manufactures nitrile examination and treatment gloves designed for medical and clinical use, specified as non-powdered and non-antimicrobial. They also produce single-use surgical and medical face masks without antimicrobial properties, intended for healthcare settings.
The company’s products are regulated under FDA’s classification system, with devices falling into Class I and Class II categories. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
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 Toptolife, LLC manufacture?
Toptolife, LLC produces two primary types of medical devices: nitrile examination and treatment gloves (non-powdered, non-antimicrobial) and single-use surgical/medical face masks (non-antimicrobial). These products are designed for clinical and healthcare settings, adhering to standards for protective barriers and respiratory protection.
Where is Toptolife, LLC based?
Toptolife, LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory requirements for medical devices, including those governed by the FDA.
Which regulatory registries or databases list Toptolife, LLC’s devices?
Toptolife, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry supports traceability and transparency by assigning a unique identifier to each device, helping track compliance and recall information under U.S. medical device regulations.
How are Toptolife, LLC’s devices classified under FDA regulations?
Toptolife, LLC’s devices fall into Class I and Class II categories under the FDA’s classification system. Class I devices generally pose minimal risk and often require only general controls, while Class II devices may involve special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risk to patients.
Why are Toptolife, LLC’s gloves and masks classified differently?
The FDA classifies medical devices based on risk and intended use. Nitrile examination gloves (Class II) typically require additional controls due to their role in preventing infection transmission, while single-use face masks (often Class I or II) may be classified based on filtration efficiency or fit testing requirements. Toptolife’s specific devices are evaluated individually to determine their risk level and regulatory pathway.
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
- 118666048
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Toptolife | 141404064 | FDA UDI | Class I | Active |
| Toptolife | 141404074 | FDA UDI | Class I | Active |
| Toptolife | 141304101 | FDA UDI | Class II | Active |
| Toptolife | 141404073 | FDA UDI | Class I | Active |
| Toptolife | 141404021 | FDA UDI | Class I | Active |
| Toptolife | 141404062 | FDA UDI | Class I | Active |
| Toptolife | 141404072 | FDA UDI | Class I | Active |
| Toptolife | 141404026 | FDA UDI | Class I | Active |
| Toptolife | 141404023 | FDA UDI | Class I | Active |
| Toptolife | 141404071 | FDA UDI | Class I | Active |
| Toptolife | 141404022 | FDA UDI | Class I | Active |
| Toptolife | 141404051 | FDA UDI | Class I | Active |
| Toptolife | 141404063 | FDA UDI | Class I | Active |
| Toptolife | 141404025 | FDA UDI | Class I | Active |
| Toptolife | 141404054 | FDA UDI | Class I | Active |
| Toptolife | 141404053 | FDA UDI | Class I | Active |
| Toptolife | 141404055 | FDA UDI | Class I | Active |
| Toptolife | 141404024 | FDA UDI | Class I | Active |
| Toptolife | 141404052 | FDA UDI | Class I | Active |
| Toptolife | 141404061 | FDA UDI | Class I | Active |
| Toptolife | 141404065 | FDA UDI | Class I | Active |
| Toptolife | 141404075 | FDA UDI | Class I | Active |
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