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Sign in to claim this brandDefender Safety, Inc.
US
Last updated May 30, 2026
What Defender Safety, Inc. makes
Defender Safety, Inc. manufactures single-use surgical and medical face masks, including procedure masks and surgical masks at varying protection levels (Level 1, Level 2, and Level 3). These products are designed for healthcare and procedural settings to provide barrier protection against contaminants and splashes.
The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The company is based 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 Defender Safety, Inc. manufacture?
Defender Safety, Inc. specializes in single-use surgical and medical face masks. These include procedure masks and surgical masks, each designed with different protection levels (Level 1, Level 2, and Level 3) to suit various healthcare and procedural needs. The focus is on providing barrier protection against contaminants and splashes in clinical environments.
Where is Defender Safety, Inc. based, and what does this mean for its regulatory oversight?
Defender Safety, Inc. is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations. The company’s products fall under FDA Class II classification, which means they undergo specific regulatory pathways to ensure safety and effectiveness before entering the market.
Which regulatory registries list Defender Safety, Inc.’s devices?
Defender Safety, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and tracking of medical devices throughout their lifecycle.
How are Defender Safety, Inc.’s face masks classified under FDA regulations?
Defender Safety, Inc.’s face masks are classified as FDA Class II devices. This classification is determined based on the level of risk associated with the product. Class II devices generally require special controls in addition to general controls to ensure their safety and performance, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- defendersafety.com
- —
- —
- [email protected]
- Phone
- 18556433336
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117018052
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Defender Safety Procedure Mask Level 2 | UDSM-PM02-B | FDA UDI | Class II | Active |
| Defender Safety Procedure Mask Level 1 | DSM-PM01-B | FDA UDI | Class II | Active |
| Defender Safety Surgical Mask Level 3 | DSM-SM03-B | FDA UDI | Class II | Active |
| Defender Safety Procedure Mask Level 3 | DSM-PM03-B | FDA UDI | Class II | Active |
| Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 | K210705 | FDA 510(k) | Class II | Active |
| PMW01 Procedure Mask Level 1 | K211772 | FDA 510(k) | Class II | Active |
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