Application to the FDA. Emergency Use Authorization (EUA)
Today, Sunday, April 5, 2020, we applied for an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The EUA is a special process whereby product designers and manufacturers can apply for a "quick review" from the FDA in times of crisis such as the current Covid-19 pandemic.
The application asks for detailed information regarding what the product does, how it works, why it works, what data you have to prove it, etc.
We will keep you posted as we progress through the FDA EUA application and review process.
About the Mask-Sanitizer:
The Mask-Sanitizer is a Portable On-Site Face Mask Disinfection Chamber for disposable face masks. The disinfection method is eight (8) germicidal UV-C bulbs positioned in front of and behind the N95 face masks. 10 face masks can be disinfected during each 15-minute cycle. The Mask-Sanitizer can be used at hospitals, fire stations, police stations, nursing homes, etc., and can be located near the actual point of use. One or more mask-sanitizers can be located at each station, department, wing, hallway or emergency room, so there is no need to handle and disinfect mass numbers of masks at a central or off-site location. The Mask-Sanitizer is simple to operate, easy to roll around, and versatile enough to be transported in the back of a minivan or SUV.