From Medscape, outlining some of the complexities for N95s:
Hansa: Now what about those... There might be people wondering right now that, "Well, why manufacture it here when you can get these masks from China?" But recently, as you pointed out in an email to me, the United States pulled the emergency authorization use role, and it's now directing everyone to certain manufacturers. Is that going to be a limitation?
Dr Blum: Oh, that's going to be a huge limitation. We're talking now about the N95. The face shields, they haven't put any stops on anything coming in from China. But N95 masks, absolutely. There've been some scary statistics of people that have randomly tested these masks that they've gotten because a friend of a friend knew someone that had a connection in China and they could get you face masks or, "Oh, I've bought these face masks. I need 50% down." And this is what we call quote unquote, gray market purchasing of these face masks. And for a long time, a long time in COVID world, this was acceptable because of this emergency use authorization that said things like you can use KN95s, you can use masks that have fit this emergency use authorization, which is an authorization put out by the FDA that says, "Listen, you can use this stuff, but it hasn't gone through the rigorous testing that we typically have, but we're okay with you using it in this situation."
Dr Blum: It offers a little bit of guidance, it alleviates a little bit of liability, but what they were finding from a lot of these masks coming in from China is that they were counterfeit and they weren't meeting the N95 specifications. Their filtration ability didn't meet that specification. So for everyone out there, I think it's important to understand what that N95 actually means. Most people that are going to be listening to this are physicians so I hope that they understand that concept of an N95 mask has to tightly fit the face and pass what's called a fit test, meaning that when they spray saccharin or a bitter substance into a air hood and you go through a series of events, that none of that material is going to get through around the edges. You're not going to taste it, you're not going to sense it.
Dr Blum: That's great. That tells you only about the fit of the mask. So these N95 masks, these counterfeits, these ones that don't meet the filtration standards, probably could still pass a fit test so people are assuming that they're safe. The fit test does not tell you anything about the actual filtration of the mask. N95 stands for the fact that, well, the N stands for the fact that they're not oil resistant, but the 95 says that they're able to filter 95% of these small particles, these 0.3 micron particles. The only way to do that is through specific testing standards and a fit test is not one of them. So it really took people to take these masks and realize that the fit test wasn't enough to say that these were safe, send them off and have them tested in laboratories to realize that some of these masks weren't meeting that standard.
Dr Blum: Now we're in a conundrum because a lot of people were getting their face masks from these outside suppliers. I believe it was 60 suppliers that have now been removed from the FDA as being okay for purchasing from. I think the number was that it's down to 14 that are safe to purchase from, and we need millions, we need arguably billions, if these are being truly used properly. So then we have to start looking at alternative solutions. That's one thing that's one of the first projects I mentioned, our face shields were a quick win project, but our long term win project was the concept of, we need something reusable. We need a reusable N95 mask out there. So that's been our long play, if you will.
Dr Blum: We knew that we would never get this out to market in a month or 2 months, and even the concept of getting something out to market in 3 or 4 months is a huge, huge win because you have to do it safely. The consequences of not doing it safely are too drastic and too dramatic, and so we're working on this N95 project now.