I want to be as transparent as possible about this project, and I’ll do it, therefore, writing these lines in first person and putting my name at the bottom.
This face mask was born with two clear objectives in mind: to guarantee safety to the wearer and to offer, at the same time, an aesthetic customization that would allow it to be worn with greater confidence.
Bringing this project to certification has been my desire since the beginning, however the road to certification is long, expensive and particularly complex for products so far from the standard.
For this reason, to date, I have not yet managed to obtain this certification. The law therefore requires me to write this warning:
This is not a Personal Protective Equipment or a Medical Device and therefore cannot guarantee the protection of the wearer’s respiratory tract. It cannot be used in healthcare or in work environments where the use of MD or PPE is required.
Honestly, I am very sorry to have to write this, because it does not do justice to the hard work done in recent months to try to make this product the best and safest possible.
Unfortunately, up to now, it has not been possible for me to certify these masks as a medical device since, the UNI standard that regulates their certification, defines tests that are normally performed on masks built entirely of filter material (surgical masks) and which do not lend themselves to being performed on a rubber and fabric mask.
With regard to Personal Protective Equipment, such as FFP2 or FFP3 masks, the standard that regulates their certification clearly states that:
“The half mask is made up entirely or mainly of filter material …”
And this statement also precludes my product from being certified.
Other types of interchangeable filter masks can be certified for industrial use, but obviously, the tests to pass are linked, in fact, to industrial use for which my mask was not designed.
The positive fact is that it seems that something will be done to make this type of product more easily certifiable in the near future.
After this long and boring introduction, of which I apologize, I would like to say, however, that I can give you some guarantees on a constructive level and I want to give them anyway. I just ask you to spend another two minutes reading the Materials tab. It will then be up to you to decide independently if these guarantees can be satisfactory, despite the absence (for now) of a certification.
The filters of the Gekomask masks are made of SMS-type Polypropylene Non-Woven Fabric, whose central layer is produced with Meltblown technology and has fibers with a thickness between 1.5 and 2 den. This type of fabric, according to tests carried out by the Politecnico di Torino, has a bacterial filtration capacity (BFE) of over 95%, while maintaining good breathability. The material is also Oeko-Tex Standard 100 certified, and this guarantees total safety of use.
The soft rubber mask has been modeled based on 3D scans of real faces and has been designed to adapt perfectly to any face, so as to ensure an almost watertight seal thanks to a suction effect that is activated upon inhalation. This suction effect ensures that all the inhaled air passes through the filter, and not sideways as occurs in common surgical masks.
The mask is made with the best medical rubber, a product totally safe for use in contact with the skin and hypoallergenic. This type of rubber costs three times more than other commonly used products (such as PVC), but has the great advantage of being, unlike the latter, completely odorless.
The filter holder is equipped with a threaded (screw) mechanism so that changing the filter is quick and easy. The cap of the filter holder screws against the rubber mask, so that it acts as a gasket itself. There is therefore no way that air can pass except through the filter.
This piece is made of food-grade polypropylene (Moplen), a very robust and completely recyclable material.
The fabrics that make up the outermost layer of the Gekomask mask are all made of natural, fresh and breathable cotton and are double-face. They uncouple very simply from the rubber part and can be washed at 60 °.
This component, in addition to fulfilling an aesthetic function and offering a wide range of customization, has the important task of exerting pressure on the center of the mask, in order to ensure that suction effect mentioned above.
In the future, we could offer versions made with synthetic stretch fabrics, but it will always be our concern, as well as for cotton fabrics, which are all Oeko-tex Standard 100 certified, in order to guarantee maximum safety in use in contact with skin.
The companies that assist us in the production of the different components of the Gekomask are all companies with great experience in their field and can boast some of the most restrictive certifications in the field of quality and safety. Among them:
- UNI EN ISO 9001:2008
- RoHS (2002/95/CE)
- REACH (EC 1907/2006)
This project would certainly not have seen the light without the precious help of our sponsors. Our gratitude, therefore, goes to them.