This mask is made of cotton and has been tested to comply the minimum requirements for masks level 3 for general population. It is reusable at least up to 10 washes based on the Citeve report No. 8206/2020.This mask cannot be used by health professionals in the performance of their duties. Thus, not being a medical device, it does not comply with the regulation of surgical masks (Regulation EU/2017/745), nor being a PPE, it does not comply with EU/2016/425 Regulation.