Filtering Facepiece Respirators
Our pressure molding technology forms a shell-type respirator providing a perfect seal with the face. The memory foam seal provides unmatched comfort, which allows healthcare professionals to wear the respirator for longer periods of time.
Our respirator has passed the leak tests (also known as a fit-tests) outlined by NIOSH. Our one-size-fits-many respirator accommodates more than 80% of face morphologies. Having one respirator model with such a high success rate facilitates logistics by reducing the number of models required to satisfy the diversity of face morphologies.
Our mask adheres to the requirements necessary to comply with Canadian standards for the equivalent of an N95 mask.
In addition, our industrial processes meet the rigorous quality management conditions required to act as a supplier of medical equipment in Canada.
Currently, the Canadian respirator guidance is based on NIOSH certificate requirements and promotes a comparable safety standard. The respirators certified through the Canadian program are designated 95PFE. We have received the designation FFR 95PFE-L1
Health Canada approved – our authorization reference number is 315509.
Bringing together supply partners located nearby in North America helps eliminate supply-chain ruptures in the event of future sanitary emergencies.
Production of our mask relies largely on Canadian components, though some are sourced from the United-States.
By offering our mask in health establishments across Canada and the US, we are collectively taking a large step towards being self-sufficient in N95-type masks.
PERFORMANCE TEST RESULTS
|Particulate filter efficiency||NIOSH 42 CFR 84 (TEB-APR-STP-0059) ≥ 95%||Pass|
|Breathing resistance/differential pressure||Inhalation: <35 mmH2O (343.2 Pa)
Exhalation: <25 mmH2O (245.2 Pa)
|Fit test||CAN/CSA Z94.4||One size fits all|
|Fluid resistance||ASTM F1862M-17 ASTM
Level 1 for 80 mm Hg
|Classified as ASTM Level 1|
|Mechanical strength of headstrap||Ability to withstand a 10 N force for each headstrap tested||Pass|
|Flammability||16 CFR 1610 Footnote 16 or CAN/CGSB 4.2 No. 27.5 Footnote 17 Class 1 (≥3.5 s flame spread)||Classified as Class 1|