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Postscript (2021.6.18): On June 16, 2021, the Japanese Industrial Standards (JIS) for general masks, medical masks, and infection control medical masks were established. With the spread of the new coronavirus (COVID-19), the wearing of masks is strongly recommended and has become indispensable for both daily life and medical workers. Therefore, the performance and test methods of masks have been standardized. , JIS T9001 (performance requirements and test methods for medical and general masks) for medical and general masks, and corona infection countermeasures, so that users can purchase with confidence by standardizing JIS T9002 (Performance requirements and test methods for medical masks for infection control) has been established for masks for medical personnel who wear masks.

Medical masks distributed in Japan include surgical masks, N95 respirators, surgical N95 respirators, and KN95.

These masks are used to protect medical staff and patients from infection, prevent the release and entry of fine particles and viruses, and protect against splashing of blood and body fluids. The material is non-woven fabric, and the feature is that the mesh of the filter is very fine compared to home use.However, because there is no standard for medical masks in Japan,Many products are based on the standards set by ASTM International (an international standardization and standard setting organization) in the United States.

Products based on ASTM-F2100-19 (American standard for medical masks) can filter droplets as small as 5 μm, but bacteria and viruses are smaller than that, so there is a risk that they will pass through the mask. However, when it actually scatters, it becomes droplets with a diameter of about 5 μm containing water around the particles, so it is possible to reduce the risk of infection with a surgical mask.

The N95 respirator is effective for infectious diseases such as tuberculosis, measles, and chickenpox virus, which have a diameter of 5 μm or less and are concerned about airborne infection.

N95 Respirator is a mask that meets and is approved by the National Institute for Occupational Safety and Health (NIOSH) N95 standard. In Europe and the United States, it is called a respirator as a "respiratory protective device" rather than a mask. The standard is strict, which cannot be recognized unless 95% or more of "0.3 μm particles", which are the most difficult to collect with a filter, can be collected. It is used to prevent inhalation of particulate matter, and was originally used at manufacturing sites, but it has been found to be effective in preventing tuberculosis and SARS infections, so that it can be actively used in medical settings as well. became. It is necessary to wear it correctly before using it, and a seal check is performed every time it is worn to check for breath leakage.

A mask approved by the Food and Drug Administration of the United States Department of Health and Human Service (FDA), which certifies medical devices in the United States, and is recognized as a medical device in the United States. In addition to the N95 respirator standards, it meets liquid protection and flame retardancy standards.

Masks that have been inspected by the State Administration of Work Safety (SAWS) and have cleared the GB2626-2006 standard, which is the same standard as the N95 standard in the United States, of which the GB19083-2010 number is the medical standard. is.

In the United States, the U.S. Food and Drug Administration (FDA) did not initially recognize its effectiveness, but if the spread of COVID19 in 2020 causes the Centers for Disease Control and Prevention (CDC) to supply N95 shortages, He expressed the view that the KN95 would be a good substitute. Following that, the US Food and Drug Administration (FDA) also announced a policy to approve the use if certain criteria are met, and it is now used in the field of health and hygiene.

Following this, on April 10, 2020, the Ministry of Health, Labor and Welfare of Japan also stated that "Medical masks such as KN95 that have been granted an Emergency Use Authorization (EUA) by the US FDA are equivalent to N95. It is treated as ".

However, after that, in the performance evaluation conducted by the National Institute for Occupational Safety and Health (NIOSH), which is a subordinate organization of the Centers for Disease Control and Prevention (CDC), many of them were forged even if they were made by legitimate manufacturers. We found problems such as no way to confirm whether it was a genuine product or a counterfeit product, and it did not meet the performance requirements.

In fact, even in Japan, some KN95 masks distributed by the national and local governments to medical institutions are dangerous and do not meet the standards used in medical practice, such as air leaking from the side and your breath passing through a filter. There is information that it was.

Not all KN95s are inferior, but you should be very careful when choosing them.