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 NUMBEROwners or operators of places of business (also called establishments or facilities) that are involved in the production/distribution of medical devices intended for use inRead More

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. Types of MasksSingle Use Face MasksThese are to be used by staff, employees or civilians. They offer a basicRead More

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 canRead More

FDA-Approval in the WorksOn 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 respirators. YouRead More