Infographic on the categories of medical face masks created by @gtfmcamps

Categories of face masks for healthcare use

There are currently three legal categories of face masks in Spain, if we exclude so-called “homemade” masks, which have not undergone any testing or checks to verify their filtering effectiveness. Consequently, they do not fall into any legal category.

• On the one hand, there are the Surgical Face Masks (classified as a medical device in accordance with the Directive 93/42/EEC o Regulation 2017/745 on Medical Devices). They are those used by healthcare professionals in operating theatres, which filter the air they exhale and act as a barrier against agents, particles, bacteria or viruses that the wearer may transmit through their breath to other people around them. In addition to healthcare professionals during routine surgical procedures, there are also recommended for people with symptoms, so that they do not pass the infection on to other people.

• On the other hand, there are the Respiratory Protection Masks against Particles (classified as Personal Protective Equipment in accordance with the Regulation 2016/425 on Personal Protective Equipment), which are those that they filter the air that is breathed in from outside, and so they protect the person wearing them. These masks trap agents, particles, bacteria or viruses from the environment in which we find ourselves. They are classified according to their filtering capabilities as FFP1, FFP2 and FFP3. Some feature an exhalation valve that reduces moisture build-up inside the mask, thereby providing greater overall comfort, particularly when breathing. They can be reusable or non-reusable. Non-reusable masks are intended for a maximum of approximately 8 hours’ use (one work shift). For protection against viruses, FFP2 and FFP3 masks are recommended. The latter (FFP3) are reserved for healthcare professionals in direct contact with patients.

• And finally, we have the so-called Surgical Face Masks (listed as such in the UNE Specifications 0064-1 (adults, non-reusable), 0064-2 (children, non-reusable) and 0065 (Adults and children, reusable)): these are a type of face mask that They cannot be regarded as either surgical or PPE. They are intended for people without symptoms when none of the other types of face mask are required, to reduce the risk of infection where social distancing is not possible. They are “surgical-type” in the sense that they protect the outside environment from fluids emitted by the wearer, and They have had to undergo a series of filtration tests in order to be approved.
  In addition to filtration capacity, another factor to bear in mind is the breathing resistance of the mask, which determines how difficult it may be for a person wearing the mask to breathe.