The flood of pseudo masks and respirators have made their way into the public market as well. Under tough circumstances, the FDA has been mostly successful in ensuring that the healthcare sector is getting the right PPE. However, as we have said many times, the public is left to fend for themselves. This is why AEA is doing what we are doing, bringing public masks and respirators that have met FDA standards for medical use, but allowing anyone to get them. We have not affected the medical supply lines; instead, we work to ensure our products are tested and vetted completely, allowing them to be used in either the medical or public sector in the highest standard.
This NPR article will shed some light on the challenges faced by our medical sector but bear in mind, it is happening in the public sector too.
Just in case you are wondering, our Level 2 masks have the 510k premarket review approved by the FDA, and our KN95 respirator has been on the FDA approved list right from the beginning.