The product is not a medical device.
The children's mask is 2-layer: the inner layer of cotton, the outer layer of polyester.
The face mask is intended for personal and multiple use for children. The product is not a medical device. It reduces the chance of transmitting infections.
It is washable at 60o C and ironing of the inner part is recommended. It is flexible and has elastic around the ears. Handmade in Slovenia.