Etrëma masks are not only extremely protective, comfortable and environmentally friendly. The other thing that distinguishes them from traditional reusable tissue masks is the recognition of medical authorities.
When you put something on your face to protect yourself from a virus or a toxic aerosol, it’s better to be really sure that it will do the job… Giving users assurances of safety and quality is the role of certification, the validation process by which laboratories and control bodies – themselves accredited and/or certified – perform tests in order to guarantee the level and stability of the performance of the products subject to marketing authorisations.
This is particularly important in the medical field where the consequences of equipment failure can be particularly severe. One of the reasons why washable masks could not be allowed in workplaces to replace disposable surgical masks during the pandemic, is that they were, for most of them, not certified in any way.
The designation of a surgical or procedural mask, a class 1 medical device, is therefore conditional on compliance with the requirements of EN 14683:2019 and its Annex C or ASTM F2100, which define the test conditions for the bacterial filtration efficiency, breathability, microbial cleanliness, resistance to liquid spray, and the minimum performance required to achieve this certification.
By completely redesigning the traditional “single-use blue surgical mask”, we have added in our own requirements, a better fit to maximize the seal, which we consider to be a primary requirement for overall protective effectiveness.
FRËTT SOLUTIONS has put a lot of time and money into the processes of validation and authorization of its products because in addition to being the sine qua non to their use in the health field, It is also the most effective and recognized way to prove our quality to all.
All masks in the etrëma range exceed the requirements of the European standard EN 14683:2019 on test methods for medical masks, of the class 1 of the European regulation MDR 2017/425 on medical devices and the CE marking which ensures that all risks of a product for its user have been identified and mitigated. And at the end of 2022, FRËTT SOLUTIONS received a Medical Device Establishment Licence (MDEL) from Health Canada, our consecration at home!
This way, we certify that such good news is the only thing our masks cannot filter!
-Antoine Palangié, B. Eng, M. Sc, PhDc