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Sign in to claim this brandFastenal Company
US
Last updated May 23, 2026
What Fastenal Company makes
The company manufactures nitrile and natural rubber (hevea-latex) examination and treatment gloves, all produced in non-powdered and non-antimicrobial versions. These gloves are marketed under the Bodyguard brand and are designed for medical use during procedures requiring barrier protection.
The portfolio consists of Class I medical devices, which are subject to FDA regulation under the Unique Device Identifier (UDI) system. These products are listed in the FDA’s UDI database, adhering to U.S. regulatory requirements for Class I devices. The company is headquartered 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 Fastenal Company manufacture?
Fastenal Company manufactures nitrile examination/treatment gloves and hevea-latex (natural rubber) examination/treatment gloves. All gloves are produced in non-powdered and non-antimicrobial versions and are marketed under the Bodyguard brand. These gloves are designed specifically for medical use to provide barrier protection during procedures.
Where is Fastenal Company based?
Fastenal Company is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under U.S. medical device regulations.
Which regulatory registries list Fastenal Company’s devices?
Fastenal Company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is required for Class I medical devices in the U.S. to ensure traceability and compliance with regulatory requirements.
How are Fastenal Company’s devices classified under medical device regulations?
Fastenal Company’s gloves fall under Class I medical device classification. This classification applies to low-risk devices like gloves, which are regulated under the FDA’s UDI system to ensure safety and proper identification without additional pre-market approval.
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
- 042653634
Catalogue (38)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bodyguard | XL-816EI | FDA UDI | Class I | Active |
| Bodyguard | 816EI-M | FDA UDI | Class I | Active |
| Bodyguard | M-816E | FDA UDI | Class I | Active |
| Bodyguard | 814E- M | FDA UDI | Class I | Active |
| Bodyguard | 815 BK L | FDA UDI | Class I | Active |
| Bodyguard | L-816EI | FDA UDI | Class I | Active |
| Bodyguard | 815 BK XL | FDA UDI | Class I | Active |
| Bodyguard | XL-814E | FDA UDI | Class I | Active |
| Bodyguard | S-816E | FDA UDI | Class I | Active |
| Bodyguard | L-816E | FDA UDI | Class I | Active |
| Bodyguard | 816EI | FDA UDI | Class I | Active |
| Bodyguard | XL-805E VP | FDA UDI | Class I | Active |
| Bodyguard | M-816EI VP | FDA UDI | Class I | Active |
| Bodyguard | M-805E VP | FDA UDI | Class I | Active |
| Bodyguard | L-816E | FDA UDI | Class I | Active |
| Bodyguard | S-805E VP | FDA UDI | Class I | Active |
| Bodyguard | S-814E | FDA UDI | Class I | Active |
| Bodyguard | 814E- L | FDA UDI | Class I | Active |
| Bodyguard | S-816E VP | FDA UDI | Class I | Active |
| Bodyguard | L-805E VP | FDA UDI | Class I | Active |
| Bodyguard | XL-816EI VP | FDA UDI | Class I | Active |
| Bodyguard | S-816EI VP | FDA UDI | Class I | Active |
| Bodyguard | M-805E | FDA UDI | Class I | Active |
| Bodyguard | XL-805E | FDA UDI | Class I | Active |
| Bodyguard | L-816E VP | FDA UDI | Class I | Active |
| Bodyguard | M-816E VP | FDA UDI | Class I | Active |
| Bodyguard | S-805E | FDA UDI | Class I | Active |
| Bodyguard | XL-816E VP | FDA UDI | Class I | Active |
| Bodyguard | 816EI VP | FDA UDI | Class I | Active |
| Bodyguard | 814E- XL | FDA UDI | Class I | Active |
| Bodyguard | S-816EI | FDA UDI | Class I | Active |
| Bodyguard | 814E- S | FDA UDI | Class I | Active |
| Bodyguard | L-805E | FDA UDI | Class I | Active |
| Bodyguard | 815 BK S | FDA UDI | Class I | Active |
| Bodyguard | L-816EI VP | FDA UDI | Class I | Active |
| Bodyguard | 815 BK M | FDA UDI | Class I | Active |
| Bodyguard | M-816E | FDA UDI | Class I | Active |
| Bodyguard | XL-816E | FDA UDI | Class I | Active |
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