Approval Details
| Schedule | 84A |
| Approval Number | 3348 |
| Manufacturer | San M Package Co., Ltd. |
| Approval Date | 10/12/2000 |
| Product Line | Models TN01-11 and TN01-12 |
| 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 |
Verde Trading Company LTD, Tokyo, Japan, Model VTM-0011 Verde Trading Company LTD, Tokyo, Japan, Model VTM-0021 Verde Trading Company LTD, Tokyo, Japan, Model VTM-0010 Verde Trading Company LTD, Tokyo, Japan, Model VTM-0020 Rescue Plus, Inc., Ibaraki, Japan, Model RESCUEPLUS-95M Rescue Plus, Inc., Ibaraki, Japan, Model RESCUEPLUS-95S Shirohato Company, Ltd, Nagoya, Japan, Model SHIROHATO N-95M Shirohato Company, Ltd, Nagoya, Japan, Model SHIROHATO N-95S Rengo Company, Ltd, Tokyo, Japan, Model KKY-NM Rengo Company, Ltd, Tokyo, Japan, Model KKY-NS Toray Medical Company, Ltd, Chiba, Japan, Model 9500T Tamagawa Eizai Company, Ltd, Tokyo, Japan, Model FITTY PREVENTION N95M Tamagawa Eizai Company, Ltd, Tokyo, Japan, Model FITTY PREVENTION N95S Taketora Company, LTD, Tokyo, Japan - Model 4958995S Unicharm Corporation, Japan, Models STA-M01 Medium, STA-S01 Small Kawamoto Corporation of Osaka, Japan, Model KAWA-001 Kawamoto Corporation of Osaka, Japan, Model KAWA-002 Covenant Healthcare Equipment & Consulting, Inc. of Pleasanton, CA, Model COVTN01-11 Covenant Healthcare Equipment & Consulting, Inc. of Pleasanton, CA, Model COVTN01-12 Tokyo Medical Co., models TN01-11, TN01-12 Hogy Medical Co., Ltd. Model HPR-R Hogy Medical Co., Ltd. Model HPR-S BSN Medical Australia of Victoria, Australia - Models TN01-11, TN01-12 Tokyo Medical Co. Ltd, Tokyo Japan, Model TM-950 Kowa Company, LTD, Tokyo, Japan, Model KOWA N-95 mask S (TN01-12) Tokyo Medical Co., LTD, Tokyo, Japan, Model TM-951 Kenzmedico Co., Ltd. of Japan, Model K-CM01-11 Kenzmedico Co., Ltd. of Japan, Model K-CM01-12 Logan Medical and Surgical (PTY) LTD, Kwa-Zulu Natal, South Africa, Model MAS058 (MD) MAS057 (SM) MYCO Medical Supplies Inc., Apex, North Carolina, Model MYTN01-11 (medium) MYCO Medical Supplies Inc., Apex, North Carolina, Model MYTN01-12 (small) Techno Medical Public Company Limited, Bangkok, Thailand, Model tmmx010 (medium only) Amoureli Private Limited, Hong Kong, China, Model SANIAID N95 MK95010300 Amoureli Private Limited, Hong Kong, China, Model SANIAID N95 MK95110300 Esuandemu Co., Ltd, Osaka, Japan, Model Sweet S&M N95 Mask Medium Nipro Corporation, Osaka, Japan - Models 21-331 and 21-332 Kowa Company LTD, Tokyo, Japan, KOWA N-95 mask M (TN01-11) Healthscope Operations, Melbourne, Australia, Model 99SA070M, 99SA071S Ci Medical Co., Ltd. Of Ishikawa, Japan, Model Medium and Small As One Corporation, Osaka, Japan, Model 7-872-01 and 7-872-02 Ozu Corporation, Tokyo, Japan - Model OZ01-11 Tokyo Pack Co., LTD, Tokyo, Japan - Model WILLSMILEMASK MC Medical Inc. of Tokyo, Japan, Model MW09004M and MW09004S Smith & Nephew PTE, LTD, Singapore, Model 97850284 (TN01-11) Smith & Nephew PTE, LTD, Singapore, Model 97850285 (TN01-12) Saferun Safety Supplies Co. Ltd. of Osaka, Japan, Model JM9501M and JM9501S Taketora Company, LTD, Tokyo, Japan - Model 4958995 Smiths Medical Japan, Ltd Models MS-350M and MS350S Omikenshi Co. Ltd, Osaka, Japan, Model 4957884135525 (TN01-11) JMS Co. Ltd. Models TN01-11 and TN01-12 Trapezoid Senshin Medical, Inc. models TN01-11 and TN01-12 Ozu Corporation, Tokyo, Japan - Model OZ01-12 |
| Model | |
| Rated Duration | |
| Cylinder pounds per square inch gauge (PSIG) | |
| Chemical, biological, radiological and nuclear (CBRN) Approval Date | |
| Comments | FDA Cleared as a Surgical Mask, 510 (K) 160271, (7/15/2016). Private Label version for Myco Medical Supplies cleared as a surgical mask under 510 (K) 160271. |
- CEL Data last Updated: June 1, 2026 2:21 PM
- Page last reviewed: May 28, 2026
- Page last updated: May 28, 2026
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Content source:
- National Institute for Occupational Safety and Health (NIOSH)
- Page maintained by: National Personal Protective Technology Laboratory