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Sign in to claim this brandArmbrust, Inc.
US
Last updated May 31, 2026
What Armbrust, Inc. makes
Armbrust, Inc. manufactures single-use surgical and medical respirators, as well as non-powdered, non-antimicrobial nitrile examination and treatment gloves. Their product line includes disposable surgical masks, face masks, and other barrier protection devices designed for medical and treatment settings.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded under 510(k) and UDI listings. These products are intended for use in the United States, where the manufacturer is based.
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 Armbrust, Inc. manufacture?
Armbrust, Inc. specializes in single-use surgical and medical respirators, as well as nitrile examination and treatment gloves. Their product line includes disposable surgical masks, face masks, and other barrier protection devices. These items are designed for medical and treatment environments to provide contamination control and infection prevention.
Where is Armbrust, Inc. based, and where are their devices primarily used?
Armbrust, Inc. is based in the United States. Their devices are manufactured and intended for use in the US market, where regulatory compliance is required for medical products.
Which regulatory registries or databases list Armbrust, Inc.’s devices?
Armbrust, Inc.’s devices are listed under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for medical devices in the US.
How are Armbrust, Inc.’s devices classified under FDA regulations?
Armbrust, Inc.’s devices fall into FDA Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and submission requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- armbrustusa.com
- —
- —
- [email protected]
- Phone
- 512-807-0744
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117532009
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fold Flat Surgical Mask | 850022550218 | FDA UDI | Class II | Active |
| American Kid Disposable Face Maks | 850022550249 | FDA UDI | Class II | Active |
| 3-Ply Disposable Surgical Face Masks | 850022550003 | FDA UDI | Class II | Active |
| Target Up&Up | GLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M | FDA UDI | Class I | Active |
| American-Made Surgical Mask | K210101 | FDA 510(k) | Class II | Active |
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