What do the ASTM Levels mean on Surgical Mask packaging?

Anyone who regularly uses disposable masks might notice that the outside packaging lists an ASTM Level rating. And you might be wondering, is this even important? The short answer is yes, absolutely.

ASTM Certification is given to products like face masks to determine the level of filtration effectiveness. When it comes to assigning an ASTM rating, here are a few aspects taken into account:

  • Amount of bacterial filtration
  • Amount of particulate filtration
  • Breathability
  • Flammability
  • Liquid barrier penetration

What are the ASTM levels for face masks?

Masks undergo extensive testing by a trusted third-party laboratory, and assigned one of three ratings:

Level 1 - Unable to filter out microscopic particulate matter (such as viruses), NOT rated for medical use. Level 1 masks are unregulated by agencies like the FDA.
Level 2 - Able to filter out particulate matter of microscopic viruses such as the novel coronavirus. Level 2 masks must be FDA listed to gain approval for medical use. Product CANNOT be called “surgical” without it.
Level 3 - Meets all the requirements necessary for Level 2 certification. Additionally, Level 3 rated masks must pass synthetic blood and fluid penetration testing. Level 3 rated masks must also be FDA-listed for medical use.

To ensure high standards, masks are put through rigorous testing. Armbrust conducts many of its own tests in house using a synthetic blood penetration machine. Blood is shot directly at a mask to mimic a worst case scenario––in this case, arterial spray––to see how it holds up.

What do the ASTM levels mean on surgical masks? Let Lloyd Armbrust explain...

ASTM has these different standards. They have level one, level two, and level three. Level one is the easiest to make and the lowest quality. And level three is the best possible quality. [The rating is based on] a variety of different things.

Bacterial and particulate filtration

They look at bacterial filtration. A level one mask has 95 percent bacterial filtration, down to 0.3 microns. Level two masks has a 98 percent filtration. Then there’s particulate filtration. Are we stopping bacteria? Are we stopping particulates? And particulates are like, really small things, right?

And so what they do is take latex particles that are 0.1 microns or even smaller, and they test to see if those get through. Now, for level one, it’s a 95 percent pass/fail. If you can 95 percent of those particles, you’re making it in. Level two is 98 percent, and level three is also 98 percent. 

Breathability and flammability

There are a lot of other things around breathability and flammability that you have to meet, which is more a checkbox. Like, does it burst into flames when you blow out your birthday candles? No? Good! It passes. 

Liquid barrier protection

But the big thing, the biggest difference between every category is “liquid barrier penetration.” So, we actually have here [at Armbrust USA] a liquid penetration machine, or a synthetic blood penetration machine. We don’t use real blood, we use synthetic blood. 

And what we do, is we test to see if in the worst case scenario, which is arterial spray, would that penetrate your mask? And this is what really separates a surgical mask from other masks.

Which ASTM level are Armbrust face masks?

Armbrust masks are  FDA-listed, and not only passed the ASTM Level 3 tests with flying colors, we even showed our work.

Because Armbrust masks carry ASTM Level 3 rating, this means they filter out 99.2% bacterial & particulate filtration down to 0.1 microns, which makes them excellent as a first line of defense against COVID-19. For more info, and to see the synthetic blood machine in action, check out the video above.