Approval Details
| Schedule | 84A |
| Approval Number | 5411 |
| Manufacturer | Makrite Industries, Inc. |
| Approval Date | 4/19/2011 |
| Product Line | Model 9500-N95 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 |
PDS International PTE LTD, Singapore Majestic Glove, Everett, WA Seattle Glove Inc., Mukilteo, Washington Andanda Industry Technology (Shanghai) Co., Shanghai China Zhou Medical Solutions LLC, Houston, Texas Blue Golf LLC., Jackson, Wyoming Precept Medical Products, Arden, NC Medacure Inc., East Orange, New Jersey Gateway Safety Inc., Cleveland, Ohio Techniweld USA LLC, Atlanta, Georgia Pasture Pharma Pte. Ltd., Singapore CMG Humanpack, Cali, Columbia Amston Tool Company, Amston, Connecticut Carrujo Empresarial, SRL, Santo Domingo, Dominican Republic Protective Industrial Products, Albany, New York Dynarex Corporation, Orangeburg, New York Abatix Corporation, Mesquite, Texas Progressive Medical Corporation, Pasig City, Philippines PowerPak Civil and Safety, Congers, NY Gantec Polysafe, Quebec City, Quebec, Canada Nogider (Shanghai) International, Trade Co., LTD, Shanghai, China Fairwin International LTD, London, England Henox Safety Group, Selangor Darul Ehsan, Malaysia WTR International, Pte, Ltd., Midview City, Singapore Great Hawk Air Service, Seattle, Washington Aragoon Pty, Ltd, Homebush South, NSW, Australia Vanguard International Solutions, Inc., Cumming, Georgia BlackHawk Industrial, Broken Arrow, Oklahoma Home Depot, Atlanta, Georgia Smart Glove International, Pte, Ltd., Singapore Direct Supply Manufacturing Inc., Milwaukee, Wisconsin Pan Taiwan Enterprise Co., Ltd, New Taipei City, Taiwan Rite-Craft Ind. Corp., Taipei, Taiwan S2S Global, Charlotte, North Carolina Dentec Safety Specialist Corp., Lenexa, KS Apothecary Products, LLC, Minneapolis, MN Emerald Professional Protection Products, Somerset, New Jersey Magid Glove and Safety Manufacturing Co., LLC, Chicago, Illinois Nelson-Jameson, Inc., Marshfield, Wisconsin Sunwell Dynamics Resources Corporation, Taipei, Taiwan Medline Industries, Inc., Mundelein, Illinois VWR International, LLC, Radnor, Pennsylvania Ouebee Safety Technologies (Int'l) PTE, LTD, Singapore First Aid Direct, Mason, Ohio Safe Care Medical, Inc., Atlanta, Georgia Cardinal Health, Waukegan, Illinois Safety Zone, Centerbrook, Connecticut Harbor Freight Tools, Calabasas, California Harbor Freight Tools, Calabasas, CA Grainger International, Inc., Lake Forest, Illinois Livingstone International Pty Ltd., New South Wales, Australia The Home Depot, Atlanta, Georgia Essendant Company, Deerfield, Illinois Brighton-Best International, Long Beach, California Symak Sales Co., Quebec, Canada MonotaRO Co., Ltd, Hyogo, Japan CVS Pharmacy, Inc., Woonsocket, RI Specialist Mobile Safety Supplies, Sdn, Bhd, Johor, Malaysia TZ Acquisitions, Knoxville, TN Radians, Inc., Memphis, Tennessee OX Group USA, LLC, Webster, New York Armateck of Newport News, Virginia SAS Safety Corporation, Long Beach, CA Pyramex Safety Products, Collierville, TN Herramientas Importadas Monterrey SA DE CV, Apodaca, Mexico Latoplast Ltd., Ontario, Canada |
| Model | |
| Rated Duration | |
| Cylinder pounds per square inch gauge (PSIG) | |
| Chemical, biological, radiological and nuclear (CBRN) Approval Date | |
| Comments | Also cleared by the FDA as a surgical mask. Private label version NON24506A, Medline Industries Inc., cleared by the FDA as a surgical mask, 01/04/2013. Private label version FMN95RN, Livingstone International, cleared by the FDA as a surgical mask, 09/27/2013. Private label version 65-3395, Precept Medical Products cleared by the FDA as a surgical mask, 05/19/2014. FDA 510K number K020474. Private label version F405-604 Apothecary Products LLC cleared by the FDA as a surgical mask, 11/19/2014. Private label version N9500A Emerald Professional Protection Products cleared by the FDA as a surgical mask, 1/14/2015. Private label version 399575, CVS Pharmacy, cleared by FDA as a surgical mask, 10/8/2015. Private label version 8624, SAS Safety, cleared by FDA as a surgical mask, 12/8/2015. Private label versions AD2N95A Dentec Safety, 305050A First Aid Direct, N95CMA Ammex, 270-2000A Protective Industrial Products, RS-900-N95A The Safety Zone, and RM10 Pyramex Safety Products cleared by the FDA as a surgical mask, 07/11/2016. Private label version Z120101, Zhou Medical Solutions LLC, cleared by the FDA as a surgical mask. Model GH9500, Great Hawk Air Service, cleared by FDA as a surgical mask. |
- CEL Data last Updated: November 1, 2024 12:00 PM
- Page last reviewed: September 3, 2024
- Page last updated: September 3, 2024
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Content source:
- National Institute for Occupational Safety and Health (NIOSH)
- Page maintained by: National Personal Protective Technology Laboratory