FDA-APPROVED & MADE IN THE USA. 
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Bacterial Filtration Efficiency 

"Bacterial Filtration Efficiency” is a test that shows the amount of bacteria that can get through our masks. A suspension of aerosolized Staphylococcus Aureus was applied to the mask through a nebulizer at a constant flow rate and fixed air pressure to test the Filtra Systems masks.

Our masks passed with a 99.59%+ Efficiency 
well above the ASTM-F2101-19 requirements

Particle Filtration Efficiency  

“Particle Filtration Efficiency” tests the size of particles that can pass through a mask. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the mask in a minute.

Filtra Systems masks blocked 99.54% of the 0.1 micron particles tested. 

The 0.1 micron (100nm) is the approx size of the size of the CoronaVirus
(SARS-COV-2) - Link

Differential Pressure
(Delta P)

The Delta P test is performed to determine the breathability of test articles by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate.

This test is used to determine the breathability of Filtra Systems surgical masks. Being able to block virus and being able to breath through the mask is imperative to our mask's comfortability. 

Flammability Test

Meant to ensure that a face mask will not ignite and burn for more than 3.5 seconds. All of our masks burned for less time, passing this requirement.

IBE - Ignited But Extinguished (IBE)

Synthetic Blood Penetration

This procedure was performed to evaluate surgical face masks and other types of protective clothing materials designed to protect against fluid penetration. The purpose of this procedure is to simulate an arterial spray and evaluate the effectiveness of the test article in protecting the user from possible exposure to blood and other body fluids. Our masks tested passed synthetic blood spray at 120 mmHg with no penetration seen. 

Biocompatibility Test

Biocompatibility test results are used to show the propensity, or likelihood, of a fabric to cause dermal irritation or dermal sensitization. Typically some level of biocompatibility testing on each of its products or uses data from previous tests for products having similar composition. When a similar, or surrogate, product is used rather than conducting new testing, the results obtained from the surrogate are expected to have the same result as if the actual product was tested.

The products containing the raw materials in the Goods listed above have been tested and the summary of the results are shown below:

• The product is considered ‘non-cytotoxic’ (Cytotoxicity test)
• The product is ‘not expected to induce clinically significant skin-irritating propensities’ and ‘not expected to induce clinically significant skin-sensitizing propensities’ (Repeat Human Insult Patch Test)

Based on this data, the Goods listed above are considered to have a ‘low potential for irritation’.