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Theory Discussion
surgical masks generally do not require FDA approval

Moderators: Lord of the Board, jesster, ryloc

good wood

Posts: 12

surgical masks generally do not require FDA approval  
  Started at Mon Apr 20 20:01:47 2020
Concordia University is the Wisconsin nonprofit organization with the strongest 3D printing capabilities. It quickly took action to fill the gap in the production of one of the medical supplies necessary for professionals to fight the new coronavirus.
COVID-19 has caused a shortage of N95 heavy-duty masks worldwide, and medical staff use N95 heavy-duty masks to avoid pollution. While manufacturers around the world are struggling to find innovative ways to maximize production, Concordia and regional partners are doing their part to serve their home communities.
Concordia relied on the direct input of medical professionals in the frontline area and worked with UWM's Prototype Center to determine an ideal printing mask prototype for the n95 model. Their research results have not been certified by the National Institute of Occupational Safety and Health (NIOSH) because their concerns are so serious that they have no time to study them. However, this is exactly what the doctor ordered.
"We heard from the medical community that they need masks and they need them now," said Dr. Dan Sem, Dean of the Batterman School of Business at Concordia. "Our goal is to produce and deliver these N95 prototypes as soon as possible to ensure that medical professionals use them as safely as possible. Internal experts in health care institutions are aware of the limitations of certification and are conducting their own evaluations, but they now need masks. "
Although the average university has up to several 3D printers, Concordia ís new Makerspace laboratory has 30 machines. Everyone is currently busy printing prototypes all day. Within 24 hours, Concordia's Makerspace can print more than 70 masks in one design.
Click here to donate and Concordia raises funds for making more masks https://www.maskwholesales.com/wholesale-n95-mask-respirator.html.
Two local manufacturers estimate that in order to produce large-scale solutions within two weeks, a total of about 1,000 masks will be required. These manufacturers include HUSCO International, a global automaker headquartered in Waukesha, and Briggs and Stratton, a Fortune 1000 manufacturer based in Wauwatosa.
Sem is an entrepreneur with extensive experience in the fields of chemistry and pharmaceuticals. He was invited to show Concordia's prototype to the team of children's hospital doctors and leaders of HUSCO and other regional organizations.
Dr. Ken Harris served as a lieutenant in the Milwaukee Police Department. He took the lead in convening law enforcement personnel within the Milwaukee Police Department and sent them safely to Children's Hospital after the product was completed Children's Hospital) and Froedtert.
In recent weeks, I have started to call myself a lawyer wearing a mask half-jokingly. I say this because I spend a lot of time every day dealing with companies that want to buy masks and other personal protective equipment from China and those who want to buy personal protective equipment from China.
Our Chinese lawyers continue to receive phone calls and emails about face masks, gloves, goggles, glasses, robes, hoods, face masks, respirators, and shoe covers. We also work with some companies to try to find fans. At the same time, Chinese individuals and companies that want to sell PPE to the United States often contact us via phone, email, and (mainly) WeChat.
There are basically two types of buyers:
Individuals or companies "know some people in China who want to sell large amounts of PPE" and hope to quickly profit from the purchase and resale of these devices.
Medical service providers (mainly hospital organizations) desperately want PPEs to protect their medical personnel Wholesale Surgical Mask.

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