Our Tests

U-Mask is a true technological revolution.

U-Mask Model 2.2 is classified as a Class 1, Type 2R MD (Medical Device) in European Countries

and sold as a general-purpose mask in the rest of the world.

U-Mask Model 2.2 is NOT registered as a PPE (Personal Protective Equipment).

Test

Test Goal

Test Method

Result

Bacterial Filtration Efficiency (BFE),

In → Out, (%)

A measurement of a mask material's resistance to penetration of bacteria, from the inside to the outside of the mask.

UNI EN 14683:2019

99,89 %

Breathability (Pa/cm^2)

Aimed at determining the air permeability of the mask.

UNI EN 14683:2019

57,8 Pa/cm^2

Bioburden (UCF/g)

An assessment of the absence of a population of viable microorganisms on the mask and / or packaging.

UNI EN 14683:2019

7,3 CFU/g

Splash test (kPa)

Detects the resistance of the mask to the penetration of blood splatters or synthetic liquids

UNI EN 14683:2019

Passed

Biocompatibility & Toxicological Report Biolayer

Check for the absence of negative or unwanted side effects generated by the materials used to build the mask (allergies, redness, irritation, toxicity, etc.).

ISO 10993-1:2018

Passed

Bacterial Filtration Efficiency (BFE),

Out → In, (%)

A measurement of a mask material's resistance to penetration of bacteria, from the outside to the inside of the mask.

UNI EN 14683:2019

99,88 %

Particle Filtration Efficiency (PFE) (%)

Evaluates the nonviable particle retention or filtration efficiency of masks, usually at sub-micron levels.

ASTM F2299 / F2299M

98.50 %

Antiviral Activity on Biolayer (Human Coronavirus 229E)

States the difference of the infectivity titer of the virus found on an antiviral-treated product compared to an untreated product after inoculation with and contact to the virus.

ISO 18184:2013

99.90%

Antibacterial Activity

on Biolayer

(Staphylococcus aureus and Klebsiella pneumoniae)

States the difference of the infectivity titer of bacteria found on an antibacterial-treated product compared to an untreated product after inoculation with and contact to bacteria.

ISO 20743:2013

99.995 % and 99.959 %

Antibacterial Activity after Aging on Biolayer (Staphylococcus Aureus and Klebsiella pneumoniae)

States the difference of the infectivity titer of bacteria found on an antibacterial-treated product compared to an untreated product after inoculation with and contact to bacteria, after materials are aged.

ISO 20743:2013

99.797 % and 99.861 %

Bacterial Filtration Efficiency (BFE),

In → Out, after 200 h

in-vivo (%)

A measurement of a mask material's resistance to penetration of bacteria, from the inside to the outside of the mask; performed on masks that have been used for 200 hours.

UNI EN 14683:2019

99,89 %

Breathability, after 200 hours in-vivo (Pa/cm^2)

It is aimed at determining the air permeability of the mask; performed on masks that have been used for 200 hours.

UNI EN 14683:2019

43.4 Pa/cm^2

Splash test after 200 hours in-vivo (kPa)

Detects the resistance of the mask to the penetration of blood splatters or synthetic liquids; performed on masks that have been used for 200 hours.

UNI EN 14683:2019

Passed