Sunday, 5 April 2020

Standards for N95 Respirators and Surgical Masks

I'm not a medical professional, but as a mother of a young baby and daughter of parents who are over 60 years old, I ended up doing so much reading up on masks/respirators that I thought I may as well collate my thoughts together in a post like this which might be useful for others to understand the standards for respirators and masks, and the difference between disposable dust masks, surgical masks, and N95 respirators. [Note: this post was many days in the making because I've been caring for a small and very wriggly baby, so do note that I started writing this post before PM Lee announced the 'circuit-breaker' in Singapore. I expect that guidances may change regarding masks over time...]

It is rather long, so here is a summary so you can skip to the specific sections quickly...

Pitta Masks and PM2.5 pollution masks do not filter for virus particles
The difference between Masks and Respirators
N95 Respirators Standards - US Standards (NIOSH) & EU Standards (CE)
Surgical Mask Standards (EN 14683+AC Medical face masks) vs Non-medical Filtering half masks Standards (EN149:2001+A1:2009)

Pitta Masks and PM2.5 pollution masks do not filter for virus particles

Recently I made the decision to withdraw baby from infantcare (having foreseen that there would be a long period where I would be asked to work from home - that prediction has now been confirmed as reality) and as a result my parents have been coming to my house to care for baby whilst I work from home. Because this meant that my parents were exposed more than me because of their transit from their house to ours, my mother expressed worry about taking Grab. So I decided to buy some masks first and foremost for my 60+ year old parents who are in the most vulnerable category.

Two months ago, my very crafty and industrious mother tried to sew some reusable masks out of cotton - but I just was not convinced that this was safe. Even from my layman perspective, how could a cloth filter the microscopic particles of a virus? So I went online and randomly bought a packet of the first aesthetically pleasing mask I saw online - the Japanese Pitta mask. But since then, I have read the fine print: Pitta Masks cannot filter tiny virus particles. Online you can find people who have done tests on the Pitta masks and found that they "captured an astounding 0% of 0.3-micron particles".
To be fair, the Pitta mask manufacturer does not advertise it for virus protection. It is simply that online sellers are putting it up unscrupulously without mentioning the fact of the matter that PM2.5 is not enough.

Image source:
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The difference between Masks and Respirators

Having ruled out Pitta masks, I started trying to understand if I should look for Surgical Masks and Respirators.

In a 3M document I found online by their "3M Subject Matter Expert – Asia Pacific Region", they state the different purposes of the masks vs respirators. It also says that "for any airborne particulate contamination such as an outbreak of PM2.5 / PM 10/ Severe Acute Respiratory Syndrome (SARS), Avian Flu, Ebola Virus etc. only respirators and not Masks, should be used to safeguard oneself from getting any kind of respiratory diseases."

Respirators = designed to protect you from the environment
Masks = designed to protect the environment from you

N95 Respirators Standards - US Standards (NIOSH) & EU Standards (CE)

WHAT DOES A LESS THAN 0.1 MICRON PARTICLE LOOK LIKE? Does a mask really filter a less than 0.1 micron particle? Sadly, it seems that figuring out which mask can really filter such a tiny particle is impossible to us alone to judge; it is entirely down to a lab test - so you could say then that it is down to the various 'standards' that the batch of masks have to meet when they are tested in a lab. So this it led me to find out - who tests the masks to make sure they are up to the standard they say they are?

US Standard:
N95 Respirator [Filters at least 95% of airborne particles]
N99 Respirator [Filters at least 99% of airborne particles]
N100 Respirator [Filters at least 99.7% of airborne particles]

European Standard:
FFP1 Respirator [Filters at least 80% of airborne particle]
FFP2 Respirator [Filters at least 94% of airborne particles]
FFP3 Respirator Filters at least 99% of airborne particles]
Check for CE cert by looking at the cert's issuing body. Unfortunately, there isn't a centralised data base you can dial it into. For more, read here at CE-Check Support. But, I have found that some of the certifying bodies have got sites where you can enter the cert number to verify.

Besides those standards, there is the Chinese KN95 and Korean KF94 which are supposed to be equivalent in standard to N95. How do we verify them? Is there any way to verify them? I don't really know. ¯\_(ツ)_/¯

This is where it got murky... So I wanted to buy some working N95 Respirators. I dialed in "N95" on Qoo10, Lazada, Shopee and ezbuy. Here's an example of the first respirator with dodgy papers which I found on Qoo10 from the seller "Collectible Haven":

I took it one step further. I took the number they posted and checked it with the Standards body for NIOSH. THE CERT NUMBER THEY PROVIDED WAS NOT FOR THEIR COMPANY OR THE PRODUCT! It did have the same product number 1200F though, but I do feel deceived.

There were several other similar examples online but I won't go through them. You can do the sleuthing yourself if you are concerned. But here is an example where I did buy the mask, and it checked out correctly.

Here's an original box of 3M 8210 masks which on the list of N95 masks from the company, along with a diagram of how to tell if the mask is an actual N95 mask.

Source: How to check the NIOSH marking on the mask (ie: the N95 standard)

After discovering that several masks online that provided "documentation" of the masks which was fake, I decided to see what really constituted a surgical mask. They've been saying that surgical masks are what you need to wear, but that there were many cases reported in the media where people bought expensive 'surgical masks' which were very thin or suspicious. The Health Sciences Authority regulates the importation of surgical masks, and their website (currenly down) had stated that there was a difference between standard face masks (paper or cloth) and surgical masks (medical product, Bacterial filtration efficiency above 95%*).

Surgical Mask Standards (EN 14683+AC Medical face masks) vs Non-medical Filtering half masks (EN149:2001+A1:2009)

Some days back, I preemptively placed an order for what I thought were surgical masks in case we needed some.

These were the masks I ordered on Shopee from posted a screenshot of the cert

These masks said they had a CE mark which I also went back to the original agency to cross-verify. Really strange to go to the effort to see if it was true, but I did and on the website (a weird marketing-oriented platform which helps foreign/chinese companies bring products to European markets through CE and other certifications) if you dial in the code from the cert - truly the certification comes up as authentic.

But at the time I didn't check what device they were certifying for. What is "EN149:2001+A1:2009"? If you search for the original definition of the standard, this is for Respiratory protective devices: Filtering half masks to protect against particles. Which translated means it is a dust mask not a surgical mask. For a surgical mask, the European standard is "EN 14683+AC" - Medical face masks.

Source: on Shopee

Again, this wasn't false advertising on this seller's part on Shopee. They did not say it was a surgical mask / medical product. I saw the picture of the mask and I personally assumed it was a surgical mask but in fact it is only a dust mask. A high quality, authentically tested and CE marked dust mask. Fair enough to them.

What is more unclear is that there are actually many sellers who DO sell their product as a SURGICAL MASK with CE mark but then the certs they posted show it is not a normal disposable face mask or some just posted nonsense. Here are 3 different examples (but there are countless more examples of this online)

Eg: Weilan777 on qoo10 - "surgical mask" with disposable face mask cert

Eg: OurFirstStore on lazada - "surgical mask" with cert for their machinery not the mask itself

Eg: Boslun on lazada - "surgical mask" with cert for different product

Did the sellers just assume that people would just glaze over looking at the certs and assume it was all good? You could say, "who cares about standards? just get the masks to the people quickly!" but then if you are buying this to protect a loved one, you don't want to feel like you've been deceived into buying it, especially when the masks are being sold at increasingly cut-throat prices.

(There is also the question in my mind: is it ethical for me to be buying masks when there is a shortage in other countries? I acknowledge the privilege that I have to be in a comfortable financial position to purchase masks/respirators in Singapore where it is very readily sold on many consumer platforms - and also to be in a position to help others. What about people who can't afford masks, or who don't have a good home environment to spend the lockdown in? Since I am not in a position to volunteer, I looked into the organisations who are helping those who would be in need during covid-19. If you can, do consider giving to these groups:

AWARE - Vulnerable Women's Fund: The COVID-19 pandemic underscores the already stark inequalities experienced by women in areas such as unemployment, housing, caregiving and domestic violence. This March, AWARE received 619 calls - our highest-ever number of monthly calls - with many callers dealing with emotional and psychological distress, violence and abuse. We need your help to ensure that we can continue to provide our services during this period, to aid these women in crisis.

Migrant Workers' Assistance Fund: The assistance fund aims to provide emergency humanitarian assistance to distressed migrant workers. The assistance offered ranges from emergency shelter, daily essentials and basic sustenance needs to employment-related issues such as salary arrears. In the event where the migrant workers tragically lose their lives, the MWAF may also provide their next-of-kin with monetary assistance or in kind. The funds collected from our previous fund-raising activities have benefitted many distressed workers and helped them return to their home country. To continue to provide emergency humanitarian assistance and reach out to more migrant workers, who contribute to our economy.