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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.

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