Has the US FDA approved the Chinese KN95 mask? Can the United States export KN95 masks?

The latest statistics of the latest crown epidemic released by Johns Hopkins University on the 13th show that as of 17:00 on the 13th, US Eastern Time (5:00 on the 14th, Beijing time), 1,905,935 global new crown cases and 118,623 deaths have been confirmed . .

Data show that the number of confirmed cases of the new crown in the United States rose to 572,587, and the death toll was 23,078. Currently, the country has the largest number of confirmed cases and deaths. Spain has 169,628 confirmed cases and 17,628 deaths. Italy has 159,516 confirmed cases and 20,465 deaths. Countries with more than 100,000 confirmed cases include France and Germany. Among them, France has 137875 confirmed cases and 14,986 deaths; Germany has 128,208 confirmed cases and 3043 deaths.

United States
According to the real-time statistics system of global real-time new coronary pneumonia data released by Johns Hopkins University in the United States, as of 6 pm US Eastern Time on April 13, 577,307 confirmed cases of new coronavirus have been reported Pneumonia cases and 23,219 deaths in the United States, a total of 2,935,006 cases were found.

In the worst-hit New York State, there are currently 195,749 confirmed cases and 10,058 deaths. New York State Governor Andrew Cuomo announced on the 13th that New York State “the worst has passed.” Cuomo said at a press conference in Albany, the state capital: “We can control the spread, and it feels good. The worst is. If we continue to be wise in the future, the situation is over.”

At present, the number of hospitalizations in New York State and the number of patients requiring ventilators has decreased, and the incidence of new coronavirus cases has also decreased, but there are still about 11,000 new confirmed cases every day. Cuomo warned that now is not the time to relax restrictions that include social distancing, “If you relax too quickly, the numbers will immediately rise.”

Italy
According to the latest data released by the Italian Civil Defense Department, as of 18:00 local time on April 13, there were 103,616 confirmed cases of new coronary pneumonia, 20,465 deaths, 35,435 cured cases, and a total of 159,516 confirmed cases. April 12 For 18. At that time, 3153 new cases were confirmed and 566 new deaths were added.

Canada
On the 13th local time, the statistics of the new coronary pneumonia epidemic released by various provinces of Canada showed that as of now, Canada has confirmed 25,681 new coronary pneumonia cases and 780 deaths.

Spain
According to statistics from the Western Ministry of Health, as of 21:00 on the 12th local time, 3,477 new cases were diagnosed in Spain in a single day, totaling 169,496. On March 20, the last time the number of confirmed cases in a single day was lower than this number was 2833; 517 people died, a total of 17,489 cases; 2336 cases were cured and 64,727 cases were cured.

Germany
According to the real-time statistics of the German “Daily Mirror”, as of 7 pm on April 14th, Beijing time, a total of 13,072 new cases of coronary heart disease have been diagnosed in Germany, an increase of 2,218 cases over the previous session. Day; a total of 3,194 deaths, an increase of 172 from the previous day; a total of 64,300 people were cured.

United Kingdom
According to data from the Department of Health and Social Security of the United Kingdom, as of 9 a.m. local time on April 13, a total of 88,621 new cases of coronary heart disease have been diagnosed in the United Kingdom, including 4342 new cases of pneumonia in one day. As of 5 pm local time on April 12, 11,329 deaths were reported in the hospital, an increase of 717 in a single day. The data only includes patients who died in hospitals due to infections, not patients who died in social welfare institutions such as nursing homes.

France
According to the latest epidemic data released by the French Ministry of Health on April 13, the number of deaths from new coronary pneumonia in France rose to 14,967, and 574 people died that day. Currently, the number of severely ill patients is 6,821. 3,725 people died in the Greater Paris area (the worst-hit area in France), and 211 people died that day.

Russia
The website of the Russian Epidemic Prevention Command reported on the 13th that in the past 24 hours, there were 2,558 newly confirmed cases in Russia, the highest record since the country’s new crown epidemic. At present, there are 18,328 confirmed cases in Russia, distributed in 82 regions of Russia. Of these, 1470 recovered and 148 died.

Japan
According to the Japan Broadcasting Association, according to reports from governments across Japan and the Ministry of Health, Labour and Welfare, 291 new cases of coronary pneumonia were newly confirmed in Japan from midnight to 10:30 pm local time on the 13th, with a total of 7,688 confirmed cases.

Iran
According to the Arab News Network, the Ministry of Health of Iran announced on April 13 that Iran has newly confirmed 1,617 new cases of new coronary pneumonia, a total of 73,303 confirmed cases; 111 new deaths, and a total of 4,585 deaths.

U.S. FDA urgently authorized a large number of KN95 masks from Chinese companies

According to a list of “authorized masks” published on the U.S. Food and Drug Administration (FDA) website, as of April 11, masks produced by 46 companies with factories in China have obtained emergency use authorization (EUA). These include not only wholly foreign-owned enterprises such as 3M China, but also local Chinese manufacturers such as Ogilvy Medical, BYD, Zhongding Testing, Yongtai Sanlian, and Kinner Medical.

The document shows that among these enterprises that have obtained emergency use authorization, 26 companies use China’s KN95 standard to produce masks.

According to US law, masks and most medical equipment cannot be sold in the US market without FDA approval.

According to previous reports, on March 28, in order to alleviate the shortage of medical protective equipment across the country, the FDA urgently approved non-N95 masks certified by the European Union and 5 countries (Australia, Brazil, Japan, South Korea, Mexico), but KN95 masks did not receive emergency Authorization.

“There has been a surge in cases of mask shortages, but the United States rejects Chinese KN95 masks.” A report on March 29 by the US news website BuzzFeed stated that KN95 masks are a Chinese substitute for N95 masks, but the U.S. Food and Drug Administration (FDA) refused to allow them to enter. United States. The article questioned the “political reasons” behind the FDA’s decision.
The U.S. Centers for Disease Control (CDC) has stated that the effectiveness of KN95 masks is the same as that of N95, and it is one of many “suitable substitutes” for N95 masks that are “in short supply”. According to 3M, the world’s largest mask manufacturer, KN95 and N95 masks are “equivalent” and “it can be expected that their functions are very similar.”


Post time: Jan-04-2021