Medical masks belong to several classes of medical devices

Class II. Medical masks have the effect of resisting liquids, filtering particles and bacteria, and in order to ensure that medical masks have a clear isolation role, to ensure its effectiveness, the country generally included in the second class of medical devices. Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.

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 mainly obtained by physical means, not by pharmacological, immunological or metabolic means, or although these means are involved but only play a supplementary role; its purpose is to obtain by physical means, not by pharmacological, immunological or metabolic means, or although these means are involved but only play a supplementary role; its purpose is to obtain by physical means. 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 examination, substitution, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.