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Sign in to claim this brandBlackwork Worldwide LLC
US
Last updated May 25, 2026
What Blackwork Worldwide LLC makes
Blackwork Worldwide LLC manufactures examination and treatment gloves made from Hevea-latex, nitrile, and polychloroprene materials. The gloves are produced in non-powdered and non-antimicrobial variants, with the polychloroprene line available exclusively in a non-powdered form.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 Blackwork Worldwide LLC manufacture?
Blackwork Worldwide LLC specializes in examination and treatment gloves. Their products include Hevea-latex, nitrile, and polychloroprene gloves, all designed for medical use. These gloves are available in non-powdered variants, with the nitrile and latex versions also offered in non-antimicrobial forms. The polychloroprene line is exclusively non-powdered.
Where is Blackwork Worldwide LLC based?
Blackwork Worldwide LLC 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 information.
Which regulatory registries list Blackwork Worldwide LLC’s devices?
Blackwork Worldwide LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Blackwork Worldwide LLC’s gloves classified under FDA regulations?
Blackwork Worldwide LLC’s gloves fall under Class I classification according to FDA regulations. This classification applies to devices considered low-risk, where general controls are sufficient to ensure safety and effectiveness. The classification is based on factors like the device’s intended use, potential risks, and the body’s interaction with it.
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
- 045085221
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blackwork | 3010 | FDA UDI | Class I | Active |
| Blackwork | 1010 | FDA UDI | Class I | Active |
| Blackwork | 2010 | FDA UDI | Class I | Active |
| Blackwork | 2030 | FDA UDI | Class I | Active |
| Blackwork | 2050 | FDA UDI | Class I | Active |
| Blackwork | 1020 | FDA UDI | Class I | Active |
| Blackwork | 3050 | FDA UDI | Class I | Active |
| Blackwork | 2020 | FDA UDI | Class I | Active |
| Blackwork | 2040 | FDA UDI | Class I | Active |
| Blackwork | 1040 | FDA UDI | Class I | Active |
| Blackwork | 1050 | FDA UDI | Class I | Active |
| Blackwork | 3020 | FDA UDI | Class I | Active |
| Blackwork | 3030 | FDA UDI | Class I | Active |
| Blackwork | 1030 | FDA UDI | Class I | Active |
| Blackwork | 3040 | FDA UDI | Class I | Active |
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