3M N95 Home Respirator With Fluid Resistance
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- DEN060009 FDA 510(k)
- FDA Product Code
- NZJ FDA 510(k)
- Models / Variants
- 3m N95 Home Respirator With Fluid Resistance FDA 510(k)3m N95 Home Respirator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6260 FDA 510(k)
- Regulation Number
- 880.6260 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The 3M N95 Home Respirator is a filtering facepiece respirator designed to provide respiratory protection against certain airborne particles. It is classified as an N95 respirator, meaning it can filter at least 95% of airborne particles when properly fitted.
This respirator is intended for use by the general public in public health medical emergencies and is supplied as a single-use device. It is manufactured by 3M Company and has received FDA 510K clearance under product code NZJ.
Frequently asked questions
What is the 3M N95 Home Respirator used for?
The 3M N95 Home Respirator is designed to provide respiratory protection against certain airborne particles. It is intended for use by the general public in public health medical emergencies.
Is the 3M N95 Home Respirator a single-use device?
Yes, the 3M N95 Home Respirator is supplied as a single-use device. It should not be reused or shared between individuals to maintain proper protection and hygiene.
What regulatory clearance does the 3M N95 Home Respirator have?
The 3M N95 Home Respirator has received FDA 510K clearance under product code NZJ. This clearance indicates it meets certain regulatory requirements for safety and effectiveness.
How does the 3M N95 Home Respirator work?
As an N95 respirator, it can filter at least 95% of airborne particles when properly fitted. The fluid resistance feature provides additional protection against splashes and sprays.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN060009 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) DEN060009 24 fields · synced Oct 6, 2026