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Classification of masks, medical masks, ordinary protective masks

by:PHARMA     2022-11-07

Since the outbreak of the new coronavirus, masks have become a necessity for everyone. With the 'resumption of work and production' of domestic enterprises and the rapid spread of foreign epidemics, the demand for masks is even greater. 'One hood is hard to find' has become the most realistic and urgent problem facing today. To this end, many new mask manufacturers have emerged. There are also many types of masks on the market, including ordinary disposable dust masks, ordinary protective masks, medical nursing masks, medical surgical masks and so on. Masks are mainly divided into three categories: ordinary decorative masks, labor protective masks and medical masks. Ordinary decorative masks are mainly used for decoration and warmth, and cannot be used to prevent infection of the new coronavirus; labor protective masks are mainly used in labor production to prevent dust and harmful gases, etc., and belong to special labor protection products. There is some protection but very limited. These two types of masks do not need to apply for a registration certificate and a medical device production license. The protective effect against the new coronavirus is the medical mask. Medical masks are further divided into three subcategories. 1. Medical surgical masks: usually made of masks, shaped parts, straps and other components, generally made of non-woven materials, which play a role of isolation through filtration. It is used to be worn on the nose and mouth of personnel to prevent the spread of dander and respiratory microorganisms to open wounds, and to prevent the spread of the patient's body fluids to other personnel, playing a two-way biological protection role. In this outbreak of the new coronavirus, there is a certain protective effect. The blue disposable masks commonly found in pharmacies are medical surgical masks. 2. Medical protective masks: masks made of one or more fabrics that have an isolation effect on virus aerosols and virus-containing liquids. It still has a barrier effect on virus aerosols and virus-containing liquids under the respiratory airflow, and when it is taken off, the outer surface of the mask does not come into contact with the human body. It is worn on the face of personnel who come into contact with virus materials in medical institutions to prevent the spread of the virus from patients to medical personnel, such as the N95 medical protective masks in this epidemic. Has a good protective effect. 3. Continuous positive pressure ventilation mask. It is used for non-invasive ventilation support such as chronic respiratory insufficiency, improved ventilation and sleep therapy. This is generally uncommon, and only used by patients who need it. The above three small categories of medical masks belong to the second category of medical devices. According to the 'Classification Catalog of Medical Devices', disposable medical masks belong to the second category of medical devices. According to the 'Regulations on the Supervision and Administration of Medical Devices', manufacturers engaged in the production of Class II medical devices need to obtain a 'Medical Device Production License' and a 'Medical Device Registration Certificate'. It takes a long time to obtain various certificates, generally more than one and a half years. However, during the epidemic prevention period of the new coronavirus pneumonia, green channels were opened in various places, which greatly shortened the approval time for listing.
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