The UPE Model EM1920 cup-shaped respirator consists of a semi-rigid inner-shell filter media and a cover-web. It covers the nose and mouth of the wearer and is held in place by two synthetic elastic headbands, conforming to the curvature of the wearer’s nose with a malleable aluminum nose-clip.
UPE intends to manufacture American-Made N95 Respirator Masks (“N95s”) in Great Falls, Montana using its own manufactured Polypropylene (“PP”) Nonwoven Fiber Fabric, also referred to as PP Melt Blown Fiber Media (“MBFM”), which is the main protective material used in the manufacturing of N95s.
EM Mask N95 Respirator Mask
Specifications
Features
Advantages
Materials
Use limitations
Center for Disease Control (“CDC”) guidelines
The Food and Drug Administration (“FDA”)
| Component | Weight (%) | |
| A l | 96.7 - 99 | |
| Cu | 0.05 - 0 .2 | |
| Mn | Max 0 .7 | |
| Other,each | Max 0.05 | |
| Other,total | Max 0 .15 | |
| Si | Max 0 .6 | |
| Zn | Max 0 .1 |
Do not use in atmosphere whose oxygen content is less than 19.5%. Do not use on atmosphere in wich the contaminant is IDLH concentration (Inmediately dangerous to life and health). (Spray paint, oiled aerosol, gas, organic steam and casting smoke)
If the respirator becomes damaged, soiled, or breathing becomes difficult, leave the contaminated area and replace and refit the new respirator.
*FDA and NIOSH approval pending
The Food and Drug Administration (“FDA”) is the regulatory body that certifies the N95 Particulate Respiratory and surgical Mask, also referred to a “Particulate Respirator”.
The UPE Model EM1920 cup-shaped respirator consists of a semi-rigid inner-shell filter media and a cover-web. It covers the nose and mouth of the wearer and is held in place by two synthetic elastic headbands, conforming to the curvature of the wearer’s nose with a malleable aluminum nose-clip.
The Classification Name: UPE Model EM1920 – Surgical Apparel, as described in 21 CFR 878.4040
The intended use meets the Center for Disease Control (“CDC”) guidelines for Tuberculosis (“TB”) exposure control. The filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator), minimizes wearer exposure to certain airborne particles in a size range of 0.10 to 10.0 microns (“µm”), such as those generated by electrocautery, laser and other powered medical instruments.
It is designed to be fluid resistant to splash, spatter of blood and body fluids and other potentially hazardous biomaterials. It provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method). No new technological characteristics are used in the UPE Model EM1920.
Filtration Efficiency
The UPE Model EM1920 meets the National Institute for Occupational Safety and Health (“NIOSH”), a federal government regulatory agency, required sodium chloride test with particles having a count median diameter of 0.055 µm to 0.095 µm and an aerodynamic diameter of 0.3 µm; at no time can the efficiency drop below 95%.
Fluid Resistance
The UPE Model EM1920 was challenged with 100 ml (+/-) 1 ml for up to 24 hours; no fluid penetration was observed.
Multiple Sized Particles Penetration Test – The UPE Model EM1920 was challenged with particles of multiple sizes, having an aerodynamic diameter range of 0.10 µm to 10.1 µm; the filter efficiency level was greater than 99%.
Bacterial Filtration Efficiency
The UPE Model EM1920 was tested using the modified Greene and Vesley procedure; filtration efficiency was greater than 99%.
Face Fit
The UPE Model EM1920 was tested using a qualitative fit test; face seal leakage was less than 10%.
Ease of Breathing
The UPE Model EM1920 meets the requirements of the NIOSH airflow resistance test which requires initial resistance (inhalation) to be less than 35mmH2O.
Conclusion
The UPE Model EM1920 non- clinical test results, when compared with data available and/or claims made on any predicate devices, demonstrate that the UPE Model EM1920 is as safe and effective as any predicate devices and performs as well as the predicate devices used in these experiments.
