Tests and Certifications


Certified and tested as FFP2

Called the “filtering face piece” score, the FFP comes from EN standard 149:2001, maintained by the CEN, and European Committee for Standardization. This particular FFP2 score is obtained by having a filter capacity in the respirator that removes at least 94% of all particles that are 0.3 microns in diameter or larger.

The Kleio + MediCare™ Respirator Masks have been sent for six tests to ensure conformation of quality to the stringent benchmarks set by TÜV SÜD PSB.

When buying a Kleio + MediCare™ Respirator Mask, you are buying quality and safety that have been rigorously tested by an accredited, long-running company.

The TÜV SÜD PSB:

  • Has a first-rate and long-standing record.
  • Is a globally renowned organization.
  • Tests samples of products for quality and safety.
  • Offers a third-party's endorsement of products, thus providing an unbiased and objective certification.
  • Provides certification marks and certificates to products that have exhibited quality, safety, and sustainability.

International standards that are relevant to masks' manufacturing include:

  • ASTMF2101
  • ASTMF1862
  • EN14683
  • ISO10993
  • ISO13485

Our masks have been subjected to the following tests to ensure that they conform to the highest international standards.

1. Bacterial Filtration Efficiency (BFE)
Standard: ASTM F2101

Results revealed a BFE of 99.96% after testing using a Biological Aerosol of Staphylococcus aureus, with contact of the inside of the masks, proving them to possess effective and comprehensive bacteria filtration.

2. Particle Filtration Efficiency (PFE)
Standard: TÜV SÜD PSB certified

Results showed that the MediCare™ Masks could efficiently filter particles as small as PM 0.1 with 95.83% efficiency. This means that 95.83% of particulates with size equal to or greater than 0.1 micrometer could be prevented from reaching the user's nasal and oral contact points. A notable point is that this PFE efficiency is comparable to that of the N95 mask's, thus offering users the same excellent protection as the latter provides, but with superior comfort.

3. Fluid Resistance
Standard: ASTM F1862

Results indicated a resounding 32/32 pass for all test sample MediCare™ Masks when the masks were subjected to a horizontal projection of fixed volume, proving their resistance to fluids.

4. Differential Pressure / Breathability
Standard: EN 14683 Annex C

The Differential Pressures of 3 areas of each mask were tested to ensure that all areas of the mask were breathable. The average of the test specimens revealed an Average Differential Pressure of 39.2 Pa/cm2, which proved to conform to requirements listed in EN 14683 Annex C.

5. Microbial Cleanliness / Bioburden
Standard: EN 14683 Annex D

Results showed that the MediCare™ Masks far exceeds the minimum standards required. Performance requirements for medical face masks stipulates them to have a maximum of 30 Colony Forming Units per gram of mask, while the Medicare Masks only saw an average of 11.6 CFU/g.

6. Flammability
Standard: CFR 1610

All test samples of the MediCare™ masks did not ignite when exposed to burning in the flammability test. The front and back of the masks were tested, and both sides passed the requirements for the Class 1 Test Classification, proving them to be flame resistant in the event of accidents.