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Certified Equipment List
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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
Kawamoto Corporation of Osaka, Japan, Model KAWA-001
Kawamoto Corporation of Osaka, Japan, Model KAWA-002
Smiths Medical Japan, Ltd Models MS-350M and MS350S
Tokyo Medical Co. Ltd, Tokyo Japan, Model TM-950
Naniwa Company, LTD, Osaka, Japan, Model Sweet Naniwa N95 Mask M, Model Sweet Naniwa N95 Mask M
Naniwa Company, LTD, Osaka, Japan, Model Sweet Naniwa N95 Mask S
Kowa Company, LTD, Tokyo, Japan, Model KOWA N-95 mask S (TN01-12)
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
Taketora Company, LTD, Tokyo, Japan - Model 076073
Taketora Company, LTD, Tokyo, Japan - Model 076072
MC Medical Inc. of Tokyo, Japan, Model MW09004M and MW09004S
Ozu Corporation, Tokyo, Japan - Model OZ01-11
Tokyo Pack Co., LTD, Tokyo, Japan - Model WILLSMILEMASK
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
Unicharm Corporation, Japan, Models STA-M01 Medium, STA-S01 Small
Kuraraykuraflex Co., Tokyo, Japan, Model AN-1107
Minato Pharmaceutical Co. models TN01-11, TN01-12
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
Suzuken Co., Ltd., of Nagoya, Aichi, Japan, models TN01-11, TN01-12
Tokyo Medical Co., LTD, Tokyo, Japan, Model TM-951
Omikenshi Co. Ltd, Osaka, Japan, Model 4957884135525 (TN01-11)
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
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.

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