History

N95 respirators have several historical predecessors. One was a design for a cloth facemask by Lien-teh Wu, who was working for the Chinese Imperial Court in the fall of 1910 during the Manchurian plague outbreak. It was the first that protected users from bacteria in empirical testing, and inspired masks used during the 1918 flu pandemic. Another predecessor was gas masks developed during World War I, which were adapted for use by miners. They were reusable but bulky and uncomfortable due to their fiberglass filters and heavy rubber construction.

Mass production of filtering facepieces was started in 1956 in the Soviet Union (the first mass-produced model was called "Lepestok" ru meaning "little leaf" in Russian). The air was purified with nonwoven filtering material consisting of polymeric fibres carrying a strong electrostatic charge. Respirator was used in nuclear industry (as single-used PPE), and then in other branches of economy. For ~60 years, more than 6 billion respirators were manufactured. Unfortunately, the developers overestimated the efficiency (APF 200-1000), which led to serious errors in the choice of personal protective equipment by employers.

In the 1970s, the Bureau of Mines and NIOSH developed standards for single-use respirators, and the first N95 respirator was developed by 3M and approved in 1972. 3M used a melt blowing process that it had developed decades prior and used in products such as ready-made ribbon bows and bra cups; its use in a wide array of products had been pioneered by designer Sara Little Turnbull.

Originally designed for industrial use; N95 respirators became a healthcare standard subsequent to virus-blocking technology invented by University of Tennessee professor Peter Tsai, and patented in 1995. The anti-viral technology was first developed to prevent the spread of drug-resistant tuberculosis. Following the onset of the COVID-19 pandemic, Tsai ended his retirement to help alleviate shortages related to the COVID-19 pandemic, by researching N95 mask decontamination.

Many American companies stopped producing N95 respirators in the 2000s due to litigation costs and foreign competition.

Global shortages during the COVID-19 pandemicedit

On January 24, 2020, Taiwan announced that it was imposing a temporary ban on the export of masks. The respirators came to be in short supply and high demand during the COVID-19 pandemic, causing price gouging and hoarding, often leading to confiscation of masks. Production of N95 respirators was limited due to constraints on the supply of nonwoven polypropylene fabric (which is used as the primary filter) as well as the cessation of exports from China.

In Canada, the Quebec company (AMD Medicom) began making masks in 1997 through an agreement with United Medical Enterprises in Atlanta, Georgia. Medicom added factories in Shanghai in 2002, Yilan Taiwan in 2010 and France in 2011. As the pandemic escalated, China, France and Taiwan either prohibited the export of masks, or requisitioned Medicom's output for local use. The federal government of Canada came to an agreement with Medicom to buy millions of masks over the next ten years, leading to Medicom announcing plans to open a new factory; in Montreal. Novo Textiles in British Columbia quickly acquired a surgical mask making machine, and announced plans to acquire an N95 making machine as well.

In March 2020, President Donald Trump applied the Defense Production Act (DPA) against the American company 3M that allows the Federal Emergency Management Agency to obtain as many N95 respirators as it needs from 3M. In early April 2020, Berlin politician Andreas Geisel alleged that a shipment of 200,000 N95 respirators that were ordered from the American producer 3M's in China's facility, were intercepted in Bangkok and diverted to the United States. Berlin police president Barbara Slowik stated that she believed "this is related to the US government's export ban." However, Berlin police later corrected themselves and confirmed that the shipment was not seized by U.S. authorities, but was said to have simply been bought at a better price by an unnamed buyer and redirected to the U.S.

Also in early April 2020, the United States federal government, invoking the DPA, ordered 3M to stop exporting N95 respirators to customers in Canada and Latin America, and to keep them within the U.S. instead. However, 3M refused, citing humanitarian implications, and the possibility of backfire: "Ceasing all export of respirators produced in the United States would likely cause other countries to retaliate and do the same, as some have already done. If that were to occur, the net number of respirators being made available to the United States would actually decrease. That is the opposite of what we and the administration, on behalf of the American people, both seek."