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A person wears a Korean-made N95 mask. (The Ministry of Food and Drug Safety) |
The Ministry of Food and Drug Safety said Monday it has approved South Korea’s first N95 respirators for use by health professionals and quarantine workers in COVID-19 situations.
Current KF94 masks are available for the general public, as they are not medical devices. However, the N95 masks are classified as medical devices, and are only available to medical personnel.
“The N95 masks can filter 95 percent of particles of 0.3 micrometers, offering the same safety and function with imported American-made N95 masks currently used in the field,” a ministry official said.
Though an approval period of a medical device typically takes more than a year, the ministry fast-tracked the process within two months with the help of regulatory support, according to the ministry.
Though similar to KF94 masks, N95 masks exhibit differences in functions. They use head straps, not ear straps, to minimize gaps and are resistant to pollutants such as blood. Also, they are made of materials that are not inflammable and do not trigger side effects on skin.
By Kim Byung-wook (
kbw@heraldcorp.com)
