These are the services that GTF can provide to your company:
We advise you to obtain the Authorization of facilities for manufacturer / importer and the registration as a distribution company. We help you prepare the dossier to obtain the CE Marking.
In GTF we solve your paperwork related to food and food supplements. We make the revision of the labeling to adapt it to the regulations. We process the Communication of Food Supplements.
Do you need more information about our services?
Explain us a bit more about your company, your products and your regulatory needs, and we will help you find the best solution.
Categories of masks for sanitary uses and self protection in Spain
Currently we can find 3 legal categories of masks in Spain, if we do not take into account the so-called "homemade", which have not passed any test or control of filtering efficiency. And which, therefore, do not have any legal category.
On the one hand there are Surgical Masks (classified as a Medical Device according to Directive 93/42 / EEC or Regulation 2017/745 on Medical Devices). They are those used by health professionals in operating rooms, which filter the air they exhale and contain agents, particles, bacteria or viruses that the person wearing it can transmit through breathing to other people who are at their disposal. around. In addition to the health professional in the usual surgical operations, they are also indicated in those with symptoms, so that they do not infect other people.
On the other hand, there are the Respiratory Protection Masks against Particles (classified as Personal Protective Equipment according to Regulation 2016/425 on Personal Protective Equipment), which are those that filter the air inhaled from the outside, thus protecting the person wearing them. These masks retain the agents, particles, bacteria or viruses that come from the environment in which we find ourselves. They are classified according to their filtering capabilities in FFP1, FFP2 and FFP3. Some incorporate an exhalation valve that reduces the humidity inside, in order to provide more comfort in general and especially when it comes to breathing. There may be Reusable and Non-Reusable. The non-reusable ones are intended for a maximum use of approximately 8 hours (one work shift). In the virus protection function, the recommended ones are FFP2 and FFP3. The latter (FFP3) reserved for healthcare professionals in direct contact with patients.
And finally we have the so-called Hygienic Masks (cataloged in the UNE Specifications 0064-1 (adults, not reusable), 0064-2 (children, not reusable) and 0065 (Adults and children, reusable)): these are a type of masks that cannot be considered surgical or PPE. They are intended for people without symptoms when a mask of one of the other types is not necessary, to reduce the risk of contagion due to the impossibility of maintaining social distance. They are of the “surgical type” in the sense that they protect the outside from the fluids of the person wearing it, and they have had to pass filtration tests to homologate them.
In addition to the filtering capacity, another concept to consider is the resistance to breathing through the mask, which determines the difficulty in breathing that a person wearing the mask may have.