The coronavirus made the procurement of PPE, medical equipment and especially face masks for many countries to an important task. Most of the personal protective equipment is being manufactured in China, so that many countries are in need to establish sources for PPE and other medical devices in China. Since there is nothing like an international standard for PPE or medical devices, we want to give an overview of different face masks, its specifications and certifications.
In general there are 2 categories of face masks: Surgical face masks and respirators.
Surgical masks are 3 ply masks, that are also called medical face masks and are usually used by medical staff and doctors in hospitals. They are certified as medical devises and need to comply with medical standards. Surgical masks, that are not certified or compliant with the regarding medical standard are being called community masks. These community masks are most commonly used – it is what most people around the world are wearing on the street at the moment. (Also masks made of textiles or self-made face masks are being called community masks)
Respirators on the other hand, are facemasks developed for protecting workers from inhaling dust, fumes, gas and other hazardous components in the air. In general respirators are personal protective equipment (PPE), not medical devices. Respirators have a high air filtration rate and are therefore the better protection against airbone viruses. This is the reason why respirators are intensively used in times of COVID19.
3-ply masks or surgical masks are “designed to prevent infections in patients and treating personnel by catching bacteria shed in liquid droplets and aerosols from the wearer’s mouth and nose.” (Wikipedia) These masks are purely focused on delivering a high bacterial filtration efficiency (>95%) and are therefore not actually very efficient again air bone viruses. Surgical masks for use in the US and Europe need to comply with ASTM F2100 (for the US), respectively EN 14683 (for Europe). 3-ply masks that are not compliant with the standards may not be sold as surgical masks or medical masks. These masks must be labeled then as community masks.
Respirators on the other hand are classified as PPE, not medical devices. There are many respirator classifications – we want to focus on so called filtering face piece respirators, which are disposal and sometimes have an exhalation valve. In Europe disposable respirators are classified in FFP classes: FFP1 with the lowest air filtration rate and FFP3 with the highest air filtration rate. In the United States the classification is being done with an “N” followed by the air filtration percentage. The most commonly used respirator is the N95 mask, that has an air filtration rate of 95%. N95 face masks need to be NIOSH approved. During the early spread of the coronavirus disease in the first half of 2020, the high demand in respirators and protective masks, resulted in a supply chain shortage. At that time many countries and governments around the world also accepted the Chinese standard of KN95 masks.
A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain viruses and bacteria. Surgical masks may also help reduce exposure from the wearer’s saliva and respiratory secretions to others, especially during surgical procedures.Wikipedia
We have community masks are medical masks, complying with medical standards in the United States and the European Union
FFP2 Masks certified as PPE by a notified body of the European Commission; CE compliant.
FFP3 Masks certified as PPE by a notified body of the European Commission; CE compliant.