Our technology is evidence based and we always rely on 3rd party validation of the product(s).

Efficacy:

Our Silver products have shown powerful and fast bactericidal activity assessed by American (ASTM E 2149) and Japanese (JIS L 1902) reference methods in several accredited testing laboratories.

It eliminated Staphylococcus aureus (including MRSA), Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Salmonella enteritidis to below the detection limit in less than 1 hour. In some test, complete bacterial killing was observed in less than 1 minute.

The viricidal activity was demonstrated at one of the largest independent research and development organizations that ranks within the top-10 of the most Innovative Universities in the World according to Reuters. They tested our Silver fabric against Coronavirus (229E)* in different protocols and after various iterations they always saw the same result. They observed a 1,2 log (92%) reduction of the virus effectivity immediately upon contact with our silver fabric.

Note: According the following paper Human Coronavirus 229E Remains Infectious on Common Touch Surface Materials (like glass) for 5 days.

* ASTM (American Society for Testing and Materials) advises 229E as the best alternative to SARS-CoV-2 (see ASTM: Guidance on SARS-CoV-2 Surrogate Selection

The fungicidal activity of our Silver products against Trychophyton mentagrophytes was demonstrated in the JIS L 1902 test. After less than 3 hours of incubation, no colony forming units were detectable.

Regulatory Compliance:

Classification according to Medical Devices Directive 93/42/EEC and Medical Devices Regulation (EU) 2017/745

Medical Face Masks are classified according to Rule 1 for non-invasive devices, as devices that either do not touch the patient or contact intact skin only.

Classification according to the harmonised European standard EN 14683:2019+AC:2019

Medical face masks are classified as Type I and Type II according to bacterial filtration efficiency, whereby Type II is further divided (Type II and IIR) according to whether or not the mask is splash resistant. The 'R' signifies splash resistance.

Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professional in an operating room or in other medical settings with similar requirements.

Our masks have been tested at the following centers with its corresponding results:

    1. SUPRMASK Pro according to EN 14683:2019+AC:2019 at Centexbel, Belgium [Medical Device Surgical Mask Type IIR/3]
      • Bacterial Frequency Efficiency of 99,48% [ 98%] with mean particle size of 2.8 μm
      • Breathability (Differential Pressure) of 48,7 Pa/cm2 [≤ 60]
      • Splash test/ Fluid resistance: all samples passed (#32 masks)

      2. SUPRMASK Premium at South India Textile Research Association, India

      • Bacterial Frequency Efficiency (ASTM F2101) of 99,8% [ 98%] with mean particle size of 3.0 μm ± 0.3 μm
      • Breathability (Differential Pressure) (ISO 16289-2014) of 28,0 Pa/cm2 [≤ 60]
      • Particle Filtration Efficiency (ASTM F2299/F2299M-03 - 2010) of 98.89 % [ 98%] with mean particle size of 0.3 μm

      3. SUPRMASK Basic according to EN 14683:2019+AC:2019 at Centexbel, Belgium [Medical Device Surgical Mask Type I]

        • Bacterial Frequency Efficiency of 94,75 % [ 95%] with mean particle size of 2.8 μm
        • Breathability (Differential Pressure) of 13,8 Pa/cm2 [≤ 40]

        4. SUPRMASK Medical at South India Textile Research Association, India

        • Bacterial Frequency Efficiency (ASTM F2101) of 94,5 % [ 98%] with mean particle size of 3.0 μm ± 0.3 μm
        • Breathability (Differential Pressure) (ISO 16289-2014) of 20,0 Pa/cm2 [≤ 60]
        • Particle Filtration Efficiency (ASTM F2299/F2299M-03 - 2010) of 98.82 % [ 98%] with mean particle size of 0.3 μm

        Safety:

        Safety and biocompatibility was proven in a few in vitro studies. (Japan Food research Laboratories)

        • No skin sensitization was observed in compliance with ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Test for irritation and skin sensitization)
        • No skin irritation was observed in compliance with ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Test for irritation and skin sensitization)
        • No cytotoxicity was observed in compliance with ISO 10993:2009 (Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity)

         

        Interested in a Research Collaboration, please email us

         

        SHOP NOW