We will all agree that making masks is a hot business right now, but there is nothing simple about surgical masks. With the recent surge in mask demand, it seems that everyone is jumping on board the let’s-make-a-mask boat.
It’s just a simple mask, right? How difficult can it be? Not nearly as simple as you might think.
While making the masks may be relatively easy, even a “simple” surgical mask has a list of regulatory requirements it must comply with in order to achieve FDA clearance.
In this quick clip, I review the myriad requirements for these “simple” surgical masks, and talk a little bit about what a manufacturer new to the mask-making biz would need to document in order to be in compliance.
Looking for EUA submission requirements? Here’s another COVID-era mask video: https://youtu.be/STVIJBFlgy4