There is such a massive need for disposable masks in the market right now and even more confusion about it. Even the sellers and buyers themselves are confused about which type they are selling or buying. We have seen transactions in which millions of the wrong type of the masks were sold because of the lack of understanding.
The disposable face masks can look virtually identical - 3 layers, blue exterior with white trim. However, the differences do matter and have very real impacts on the safety of the end-user.
Most people in the US want to buy an ASTM Level 1 Mask. But let’s break down what that really means. To keep it simple, let’s focus on 3 things:
- Bacteria Filtration Efficiency (BFE) = % of particles filtered with a particle size of 1.0-5.0 microns
- Particle Filtration Efficiency (PFE) = % of particles filtered with a particle size of 0.1-1.0 microns
- Fluid Resistance = Resistance to penetration by synthetic blood under pressure mmHg (higher, the better)
ASTM Level 1:
PFE >= 95%
Fluid Resistance >= 80 mmHg
1) First, finding a mask with BFE over 95% is easy to achieve. After all, bacteria are larger than viruses so filtering out bacteria is more attainable.
2) Next, having a PFE over 95% is a challenge that many masks do not overcome. In fact, it is not uncommon to have an over 95% BFE mask only achieve 30% PFE. Unfortunately, most people do not even realize that there is a difference between PFE & BFE since they sound so similar.
a. NOTE: The coronavirus has a diameter of 0.12 microns so PFE (size of 0.1-1.0 microns) is more important than BFE (size of 1.0-5.0 microns)
3) To be truly ASTM Level 1, the mask also needs to have fluid resistance. This is the second major hurdle that disqualifies most masks you see being sold as “Level 1”.
While it is easy to say you want to buy a “Level 1” mask, the devil is in the details and here is what you are most likely purchasing when you buy a disposable face mask that originated from China. Let’s start from the lowest level of protection.
Disposable Protective Face Masks (Chinese National Standard GB/T 32610-2016)
- BFE=Not Required
- PFE>= 95% (BIG CAVEAT!)
- Fluid Resistance= Not Required
Protective face masks are the least protective masks that we are discussing but why do they have such a high PFE? It is because the particle size that is used to test filtering efficiency is up to 2.5 microns. That is a huge jump from the ASTM PFE standard of particle size 0.1-1.0 microns. Therefore, even if the test reports of these protective face masks show PFE over 95%, comparing this to the ASTM PFE standard is comparing apples to oranges.
Disposable Medical Face Masks (Chinese Medical Standard YY 0969-2013)
- PFE=Not Required
- Fluid Resistance=Not Required
The “Medical” labeling is causing a lot of confusion because many people assume that it must be suitable for medical settings. However, there are no requirements for PFE or fluid resistance, so it does not actually reach 2 out of 3 most important points to be considered “Level 1”.
Disposable Surgical Face Masks (Chinese Medical Standard YY 0469-2011)
- BFE>= 95%
- PFE >= 30%
- Fluid Resistance >= 120 mmHg
These “Surgical” masks based on the Chinese standards *potentially* can be compared to the US standard ASTM levels if PFE is tested to be above 95% through independent lab studies. If so, now we are in the range of ASTM standards, in which the BFE, PFE, fluid resistance are over 95% and 80mmHg.
In summary, if you really want to be buying “Level 1” masks from China, you should be looking at Disposable Surgical Masks that hit or exceed the ASTM standards. Otherwise, you might unknowingly be buying masks of lesser quality. Even masks labeled as “medical” do not hit this ASTM standard because PFE and fluid resistance are not required.
Key takeaway tips:
1) Be specific. Do not use broad terms like “Level 1” because there is no guarantee that the person you are speaking with understands what are the specifications that come with being “Level 1”, even if they are selling it to you.
2) Recognize that there are different standards and levels of these disposable masks so you cannot just go off of price alone. It is not as simple as saying you can get cheap disposable 3-ply’s for $0.25. Quality matters when it comes to protecting yourself and those you are providing for.
3) Understand what you are using these masks for. If it is just for general use and price matters more than quality and something is better than nothing, feel free to purchase disposable protective face masks. If these are going to essential frontline workers or other individuals in high risk environments, please make sure you are truly buying masks that are equivalent to ASTM Level 1 and above.
At PPE Trade and Support, we pride ourselves in really understanding the nuances of different PPE on the market like disposable face masks so that our customers can rest assured they are buying exactly what is advertised. If you or others have further questions about disposable face masks or other PPE, please don’t hesitate to reach out to us at email@example.com.