There is a tremendous amount of confusion in regards to what the FDA terms “approved” and “registered” are referring. Let’s take a deeper dive on this…. FDA REGISTRATION / OWNER OPERATOR NUMBER Owners or operators of places of business (also called establishments or facilities) that are involved in the production/distribution of medical devices intended for
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Trying to navigate all the different PPE masks can be daunting. So we thought it would be prudent to a post that would help explain the terminology and when best to use each type of mask. Single Use Face Masks These are to be used by staff, employees or civilians. They offer a basic layer
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New England Journal of Medicle Article – Aerosols and droplets generated during speech have been implicated in the person-to-person transmission of viruses,1,2 and there is current interest in understanding the mechanisms responsible for the spread of Covid-19 by these means. The act of speaking generates oral fluid droplets that vary widely in size,1 and these droplets can
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In a new study published in the journal Science, epidemiologists from the Harvard T.H. Chan School of Public Health say that in the absence of a vaccine or effective treatment, social distancing until 2022 could be necessary to contain the COVID-19 pandemic. The study, published Tuesday, says that intermittent social distancing may be necessary to control the
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From February 19 – March 2, 2020 the CDC collected samples from potentially contaminated objects in the ICU and GW in hospital wards in Wuhan, China. The study, entitled “Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020”, was conducted in two wards at Wuhan’s Huoshenshan Hospital
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We found this a very helpful visual aid in explaining the outbreak, how the virus operates, and what to do to protect yourself.
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The Coronavirus Aid, Relief, and Economic Security (CARES) Actallocated $350 billion to help small businesses keep workersemployed amid the pandemic and economic downturn. Knownas the Paycheck Protection Program (PPP), the initiative provides100% federally guaranteed loans to small businesses.Importantly, these loans may be forgiven if borrowers maintaintheir payrolls during the crisis or restore their payrolls afterward.The
Read MoreThis is the April edition of the St. Louis Metropolitan Medicine magazine with their COVID-19 coverage. Vantage points from various doctors and health care workers dealing with the coronavirus in the Missouri health care system with a focus on the need to provide more education on the virus. To wit: “More importantly, for the dismissive
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We have officially launched the website! Our first shipment of masks is en route from our factories overseas. And we have our first orders coming in! We are very excited to be able to provide this service in a time of need. And we want to thank our incredible team both here and overseas that
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FDA-Approval in the Works On April 3, 2020, the FDA issued an EUA (emergency use authorization) letter announcing that the agency will authorize the KN95 masks for use in healthcare settings if it meets certain criteria. We are currently working with the FDA to be added to Appendix A as an authorized manufacturer/importer of KN95
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