Medical and Non-Medical Mask Reference
In an effort to clear up some of the confusion around the terms and standards related to masks, I am attempting to compile relevant information and share it here. There is a lot of terminology flying around and it’s important to know what your buying depending on your planned usage.
Both the US and China have varied their strictness as it relates to masks. In the beginning of the crisis, China was trying to maintain their own supplies of medical masks and limiting exports. There was a huge supply shortage of every type of mask and hundreds of factories converted to making masks in March and April, mostly at the urging of the Chinese government. The FDA reduced their limitations on mask imports around the same time that China started opening up for export.
Initially, China export control was letting just about everything go through and letting import control do the work. This is typical because there is no way for the exporting country to know every regulation of every importing country. In the past couple of weeks China has become extremely strict requiring all PPE to have the correct marks on their packaging and documentation in place. That doesn’t mean that they are centrally controlling quality but it does mean that any masks imported from about the middle of April onward should have the right words on their packaging related to their classification.
Classification of Masks
In China, masks are divided into two main categories and further divided into multiple sub categories.
Medical Masks – masks intended to be used for protection in medical environments.
- Medical protection mask (aka Medical Respirator) – for high-risk medical environments
- Medical surgical mask – typical ‘surgical’ mask
- Disposable medical mask – basic medical mask, looks like a surgical mask but held to less strict standard. Many people have been confused because ‘disposable’ is in the title here but in fact all medical masks are disposable. Only because of the PPE shortage during COVID have hospitals been sterilizing masks but they were never designed, or certified, to be re-used.k
Non-Medical Masks – masks intended to be used for personal protection outside of medical environments, e.g. construction, pollution, etc. In China they commonly refer to these as civil masks.
- Anti-particle masks – suitable for industrial environments i.e. not specifically tested for medical purposes. These can be found in many different forms including respirator style, surgical style, full-face and others. These masks can be extremely effective depending on type but are not certified for medical use.
- Daily protective masks – for regular people walking around. Think of fashion masks.
Since most masks are coming from China, it’s important to understand how China classifies masks and then we can determine how that matches with US standards.
How to Identify Medical vs Non-Medical Masks
Exhalation valve – Medical masks typically do not have an exhalation valve. The valve makes it easier to breathe but also lets the wearers contaminants out unfiltered. Non-medical masks can have exhalation valves.
Packaging marks – The packaging for medical masks typically has the word ‘medical’ on it or “医用” in Chinese. The word ‘surgical’ is also used to indicate medical although if you are looking at packaging imported in early April or before, these words could be on non-medical imported masks inappropriately.
Global Product Standards
All masks are produced to comply with a specific standard. It’s very important to realize that the standard is just that, a standard. It is not a certification. A certification is a confirmation by a testing body that a product meets the standard.
|Standard||GB 19083||YY 0469||YY/T 0969||ASTM F2100||EN 14683|
|Description||Medical Protection Mask||Medical Surgical Mask||Disposable Medical Mask||Specification for Materials used in Medical Face Masks||Medical Face Masks|
|Regulator||National Medical Products Administration||FDA||CE|
All medical masks are classified as medical devices and are subject to ASTM F2100 standards. To sell medical masks in the US, they must be registered under FDA Section 510k.
FDA 501K registration search is available here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Due to COVID, the FDA published the ‘Appendix A’ list of Chinese manufacturers and products suitable to augment NIOSH approved supplies of N95 masks but have not gone through the full testing and evaluation protocol by NIOSH. Download link. This is in addition to all the manufacturers and products who already had certified products as there were many manufacturers pre-COVID in China making medical masks.
N95 vs Surgical Masks
The rating ‘N95’ refers to a masks ability to filter out 95% of airborne particles sized 0.3 microns or large and does not have requirement for oil resistance. The N95 mask has become well-known because it is the minimum standard recommended for providing protection against breathing in viral droplets. There are other ratings that are less stringent as well as some that are more.
Interestingly the SARS-COV-2 viral particle that causes the COVID 19 disease is ~120 nm which is much smaller than the 0.3 mcrons (300nm) filtration rating of the N95. The mask is effective because it depends on filtering the virus as part of a larger droplet.
For a N95 mask to work according to the standard it must be fit snugly to the face. In a medical environment, wearers must be fit properly to make sure they are using the correct size mask for their face
The following is a real diagram released by the CDC in 2017 showing the proper facial hairstyles to get the proper fit with respirators.
All N95 masks, medical and non-medical, must be approved by the National Institute for Occupational Safety and Health (“NIOSH”).
Since the pandemic, the NPPTL has been testing masks outside of the typical NIOSH process in an effort to help people determine the effectiveness of so many non-NIOSH certified masks. The complete list of tested masks is here: NPPTL Tested Masks
Surgical masks are loose fitting masks that primarily prevent the wearer from contaminating their environment. However, there have been studies that show surgical masks are surprisingly effective in reducing exposure of the wearer.
The diagram below from 3M does a good job explaining the regulation differences between surgical N95s, general N95s, surgical masks. In this context, surgical N95s are N95 masks certified for medical usage. All other N95s are those marketed towards non-medical purposes, i.e. industrial uses. That doesn’t mean they aren’t as effective as the medical N95s but it does mean they haven’t been specifically certified for this purpose. The main difference is that Surgical N95 masks must meet an additional requirement for resistance to penetration by synthetic blood as described by ASTM Test Method F1862. Unless there is a chance you are going to get shot in the face by contaminated blood, the non-medical N95s are suitable. This aligns with guidance by the CDC on their FAQ.
Source: 3M Technical Bulletin – Surgical N95 vs. Standard N95 – Which to Consider?
What about KN95 and FFP2?
The US has its N95 rating and other countries have their own ratings according to their standards. China has KN95 and Europe FFP2. This stratification of standards is very normal and exists throughout all kinds of standards worldwide. Typically there is a market leader that create the standard and then other countries make their own that closely follow, or are identical, to the market leaders standard.
In the case of masks, N95, KN95 and FFP2 all are very similar standards. The CDC agrees and has recommended people use KN95 or FFP2 masks when N95 masks are not available, i.e. now.
This is where it is very important to understand the difference between a certification and a standard. A mask that meets the KN95 standard or FFP2 standard would almost certainly meet the N95 standard. However, Chinese manufacturers labeling their masks KN95 do not have the same testing requirement as masks labeled N95. Instead they pay independent 3rd party testing services to test their masks against any standard they choose whereas a mask labeled N95 (and legally sold in the US) must be tested by NIOSH against the N95 standard. Most of the test reports from Chinese factories I have seen are actually tested against the EU’s EN149 standard for FFP2. Assuming the test report is legit, that should be fine because FFP2 is the EU equivalent to N95.
One issue is that KN95 masks typically have earloop elastic which are more difficult to achieve a proper fit for true 95% filtration efficiency.
Why don’t Chinese manufacturers test for the N95 standard or the KN95 standard? It’s all about maximizing their ability to export and for their customers to import. If they test for KN95 the products would not be as sale-able because importers want testing for their home country. If they certify against European standards, all of Europe could import their products. If they test against US N95 standards, the product would still not have been tested by NIOSH and thus would still fall short of US requirements.
Frauds, Fakes and Counterfeits
There are a few real problems with purchasing masks especially during a time when there are huge gaps between supply and demand.
- Frauds – Masks that claim something they definitely are not e.g. medical masks that have not been certified. Test reports that are fictitious.
- Fakes and counterfeits – Masks of a lower quality inappropriately packaged in boxes of certified or higher quality brands
Unfortunately the above problems do exist, especially when there is so much demand. Even good people get caught in the rush to provide product by cutting corners. In my experience, the most common situation is swapping out of materials without having done enough diligence hoping that it is just as good as the material it replaces.
Imagine you are a manufacturer and your regular supplier says that the meltblown fabric you need for masks is now 10x the normal price. Orders are piling up and you can either try to go back to all your waiting customers and request more money or you can go out and try to source an alternative material on the spot market. Another supplier is offering similar material but you’ve never used it before. Technically you would need to get the masks re-tested but there is no time. Orders worth a years wages are in the queue and you need to get product out the door.
This is probably a lot more common situation than we think and is my guess for why so many masks are now failing tests.
The failure may not even be known by the mask manufacturer because the same situation could be happening at the material factory. Instead of running their machines normally, they have 100x the number of orders and have turned their machines up to 11 to increase production. The mask factories may be purchasing the same exact material as before but the material quality may have changed without them knowing. During normal times all factories put raw materials in quarantine (not biologic quarantine but this is what it is called) while Incoming Quality Control checks it against the ordered specification. Only after passing IQCs tests does the raw material get out of quarantine and enter the warehouse inventory. But these are not normal times and the rush to get out product has smaller factories and newer factories cutting corners.
Choosing The Right Mask For You
The CDC has suggested that all people wear cloth masks when going out in public presumably to provide some protection while saving medical masks for healthcare workers.
But there is a false scarcity of masks. Yes, the prices are much higher than normal but as I have shown it is possible to import masks, not easy, but possible. Even an ‘extremely expensive’ mask is $5 or less, it’s a small price to pay to prevent infection.
Everyone should wear masks and in my opinion, everyone should have at least a supply of surgical style masks. Surgical style (medical or non-medical) masks are easier to breathe through and still provide surprisingly good protection in both directions. The worst myth that continues to be perpetrated is that masks are only for others and provide no benefit to the wearer. It’s simply not true. One study: https://jamanetwork.com/journals/jama/fullarticle/2749214
Now that the country is opening and it will be impossible to socially distance in many situations, masks will become an increasingly important part of our everyday carry.
If you are going to be working in a medical environment, you should try to get masks certified for medical use if at all possible. Is a non-medical KN95 better than a medical surgical mask if that is all you can find? Probably but that is up to you to decide.
For non-medical environments, any mask, medical or non-medical, will certainly be better than a cloth mask. A cloth mask is better than nothing and any mask with a filter will likely be better than that.
3M PPE Info Center – https://www.3m.com/3M/en_US/worker-health-safety-us/covid19/
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) – https://www.fda.gov/media/136449/download