Approval Details
| Schedule | 84A |
| Approval Number | 5463 |
| Manufacturer | Makrite Industries, Inc. |
| Approval Date | 6/14/2011 |
| Product Line | Model 9500-N95S N95 Filtering Facepiece Air Purifying Respirator |
| 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 |
Zhou Medical Solutions LLC, Houston, Texas Shanghai K&J PPE Co., LTD, Shanghai, China Blue Golf LLC., Jackson, Wyoming Home Depot, Atlanta, Georgia Direct Supply Manufacturing Inc., Milwaukee, Wisconsin Medline Industries, Inc., Mundelein, Illinois Quebee Safety Technologies (Int'l) PTE, LTD, Singapore Sunwell Dynamics Resources Corporation, Taipei, Taiwan Goldblatt Industries, LLC, Huntersville, NC Pan Taiwan Enterprise Co., Ltd, New Taipei City, Taiwan S2S Global, Charlotte, North Carolina Pasture Pharma Pte. Ltd., Singapore Cardinal Health, Waukegan, Illinois The Home Depot, Atlanta, Georgia Quality Impex & Trading Pte, Ltd, Singapore Fairwin International LTD, London, England Precept Medical Products, Arden, NC Updrive Trading PTE LTD, Singapore PDS International PTE LTD, Singapore |
| Model | |
| Rated Duration | |
| Cylinder pounds per square inch gauge (PSIG) | |
| Chemical, biological, radiological and nuclear (CBRN) Approval Date | |
| Comments | Cleared by the FDA as a surgical mask, 01/04/2013. Private label NON24507A, Medline Industries Inc., cleared by the FDA as a surgical mask, 01/04/2013. Private label 65-3395S cleared by the FDA as a surgical mask, 05/19/2014. FDA 510(K), K020474. Private label Z120102, Xhou Medical Solutions LLC, cleared by the FDA as a surgical mask. |
- CEL Data last Updated: June 4, 2025 12:00 PM
- Page last reviewed: March 21, 2025
- Page last updated: March 21, 2025
-
Content source:
- National Institute for Occupational Safety and Health (NIOSH)
- Page maintained by: National Personal Protective Technology Laboratory