Is a mask a medical device?

1 Depending on the "intended use" in the operating room hospital use is a medical device, at home for personal protective equipment.

2Medical device: medical device refers to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; its utility is obtained mainly through physical means, not through pharmacology, immunology or metabolism, or although there are involved in these ways, but only to play an auxiliary role; its purpose is the diagnosis of disease, prevention, monitoring, supervision, and monitoring. ancillary; the purpose of which is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the testing, substitution, regulation, or support of physiological structures or processes; the support or maintenance of life; and the control of pregnancy.