Approval Details
| Schedule | 84A |
| Approval Number | 4541 |
| Manufacturer | Makrite Industries, Inc. |
| Approval Date | 1/17/2008 |
| Product Line | Model 910-N95FMX N95 Filtering Facepiece |
| For Protection Against | N95 |
| Service Time (minutes) | |
| Facepiece Type | Filtering Facepiece |
| Is the respirator powered? | Non-powered |
| Number of Filters | 1 |
| Is the the filter replaceable? | No |
| Filter Location | Filtering Facepiece |
| Cartridge or Canister | |
| Number of cartridge or canisters | |
| Location of cartridge or canisters | |
| Is the cartridge or canister replacable? | No |
| Self-contained breathing apparatus (SCBA) Type | |
| Supplied air respirator (SAR) Type | |
| Self-contained breathing apparatus (SCBA) Use | |
| Airflow | |
| Breathing Gas | |
| Percentage of Oxygen in Breathing Gas | |
| Regulator Location | |
| Low Temperature (Celsius) | |
| Low Temperature (Fahrenheit) | |
| Exhalation Valve? | No |
| Self Rescuer? | No |
| Is the approval obsolete? | No |
| Private Labels |
Ammex Corporation, Kent, WA, Model N95F Sichuan Feel Technology Company, LTD, Sichuan, China, Model 9501FM DSI Safety, Laval, Quebec, Canada Dentec Safety Specialist Corp., Lenexa, KS AMD-Ritmed, Lachine, Quebec, Canada A.R. Medicom Inc., Lachine, Quebec, Canada Panamed Philippines, Inc., Pasig City, Philippines Jet Equipment and Tools, LTD, Coquitlam, British Columbia, Canada Jiangxi Poetaa High and New Technolog Co., China Sunwell Dynamics Resources Corp., Taipei, Taiwan, Model SW910-N95FMX Protective Industrial Products, Inc., Guilderland Center, NY, Model 270-3000 Petragon, Inc., Edwardsville, KS, Model 305090 Amston Tool Company, Amston, Connecticut Pasture Pharma Pte. Ltd., Singapore S2S Global, Charlotte, North Carolina Allergy Zone LLC, Louisville, Kentucky As One Corporation, Osaka, Japan Dynarex Corporation, Orangeburg, NY Majestic Glove, Everett, WA |
| Model | |
| Rated Duration | |
| Cylinder pounds per square inch gauge (PSIG) | |
| Chemical, biological, radiological and nuclear (CBRN) Approval Date | |
| Comments | FDA clearence as a surgical mask, 01/20/2011 under 510(K) 020474. Private label versions, 270-3000 Protective Industrial Products, AD4N95 Dentec Safety, and N95F Ammex cleared by the FDA as a surgical mask, 07/11/2016. |
- CEL Data last Updated: June 4, 2025 12:00 PM
- Page last reviewed: March 21, 2025
- Page last updated: March 21, 2025
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Content source:
- National Institute for Occupational Safety and Health (NIOSH)
- Page maintained by: National Personal Protective Technology Laboratory