As mask mandates return, the FDA gives a thumbs down to KN95 respirators. Here’s what to look for

Mask mandates are making a comeback, even for the vaccinated, as the Delta variant rips its way through the US population.

And as mask mandates return, the federal government has raised the bar on which masks are acceptable and which ones are not. The Prepared’s recommendations have stood the test of time (going back to recommending masks for Covid in January 2020), but we’ll clue you in on the new standards and what it means for the mask market.

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Maybe you’ve thrown up your hands and either go maskless or wear whatever is on hand when required. But if you’re still masking up, here’s what you need to know:

• The FDA has revoked its Emergency Use Authorization for KN95 masks, as well as reused masks
• Respirators are still the best protection against airborne pathogens
• The most common types of respirators in the United States are American N95 masks and Chinese KN95 masks
• That authorization only applies to healthcare workers, but it supports our advice from last year to avoid KN95 respirators, which are known for inconsistent quality
• The only approved respirators are those approved by the CDC’s NIOSH division, but NIOSH is also raising its standards, taking some products off the market
• Your best bet is to buy authentic N95 respirators from reputable retailers
• It’s hard to go wrong with respirators from 3M or Kimberly-Clark
• Texas manufacturer Armbrust has been testing surgical masks purchased from Amazon and maintains a database of their results
• Two surgical masks Armbrust recommends are the American-made DEMETECH ASTM Level 3 and Chinese-made Diolv 3 layer masks

A quick rundown on respirator standards

We explored the differences in respirator types in our previous article on KN95 respirators, but we’ll offer a quick rundown here. Respirators are the best form of protection against airborne pathogens since they block about 95% of airborne particles. Different countries have different standards for respirators, and the respirators are named after their country’s certification standard:

• United States: N95
• China: KN95
• Korea: KF94
• Japan: DS2
• Europe: FFP2

In the United States, the KF94, DS2, and FFP2 masks are rare. Much more common are domestic N95 and Chinese KN95 respirators. In the wake of PPE shortages, many Chinese manufacturers seemingly sprang up overnight to fill in the gap. Unfortunately, it also meant that many inferior masks wound up on shelves.

While healthcare workers are now basically forbidden from using KN95 masks at work, they’re still readily available from Amazon and other retailers. However, we advise against them due to unreliable quality standards. And given that the FDA will no longer extend the EUA, it seems as though the US government doesn’t trust them either.

The FDA raises the bar on masks

The CDC isn’t the only federal agency that’s once again shifted opinions on masks. Last year, I advised against Chinese KN95 masks due to ever-shifting and uncertain FDA guidelines. Now that mask supplies are plentiful, the FDA is raising the bar and has revoked Emergency Use Authorizations for imported respirators, as well as previously used decontaminated respirators.

The FDA said in a June 30 statement:

Today, the FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.”

These EUAs were issued during the early days of the pandemic when healthcare personnel had an insufficient supply of personal protective equipment. The FDA now believes that the supply chain has caught up, and therefore there’s no need to resort to these inferior methods of protection.

NIOSH stands for The National Institute for Occupational Safety and Health, and it’s a division of the CDC devoted to workplace safety. Last month, NIOSH raised standards for respirators, making it so many previously approved manufacturers must go back to the drawing board.

Oddly enough, the EUA for surgical masks, which offer less protection than N95 respirators, is still in effect.

The new NIOSH standards

In June, NIOSH instituted new mask standards called Workplace Performance and Workplace Performance Plus. To maintain or obtain NIOSH certification, manufacturers must adhere to the recently adopted ASTM F3502-21 standard, which specifics that masks must:

• Cover the wearer’s nose and mouth and fit snugly against the sides of the face and nose without gaps, as determined by the design analysis.
• Have a means for keeping the mask over the nose and mouth for the expected period of use and range of activities.
• Have non-irritating and nontoxic materials where the mask contacts the skin.
• Be either disposable (single use) or reusable (multiple use).
• Be able to be worn by individuals with a range of fit characteristics (excluding children under age 2), or designed with multiple sizes to allow fit for a wide variety of people in the end user population.

NIOSH also adds additional criteria for certification. For Workplace Performance, that means a leakage ratio of ≥5. Workplace Performance Plus masks must have a leakage ratio of ≥10. In plain English, a higher number is better.

In the long run, these improved standards may make it easier to shop for high-quality respirators, as the products will have Workplace Performance or Workplace Performance Plus on the package. However, in the short run, it may make it harder to buy disposable N95 respirators.

How manufacturers are responding

I personally use and recommend respirators from United States Mask, a small respirator manufacturer based in Dallas, Texas. Unfortunately, the new regulations means that they will no longer be producing their 1836 respirator:

 A little while ago, we suspended production of our Model 1836. Our 1836 N95 is certified by NIOSH under the public health emergency, which means the 1836’s approval is only effective while the emergency use of personal respiratory protective devices is in effect. United States Mask was one of a select few who were approved to manufacture N95’s under this emergency use authorization and we’re proud of that. The 1836 N95 represents what we’re capable of when Americans set their mind to something.

In the meantime, United States Mask is working on a new N95 mask and is selling its existing stock at steep discounts. A pack of 40 masks, usually $89.90, can be had for $44.95 before tax and shipping. I can vouch for their quality, and they were good enough for NIOSH not long ago.

Another small Texas-based mask maker, Armbrust, is being a bit bolder. While it waits for official government approval for its N95 mask, it’s selling it as the AA-95 mask with a big warning that it is NOT an N95 mask approved by NIOSH.

Cutting through the confusion to find quality masks

Since the start of the pandemic, I’ve been advising you to stick with government-approved masks. Unfortunately, the government’s recommendations, like many of its COVID recommendations, is a confusing trainwreck. It maintains a list of NIOSH-approved respirators, which is great in theory, but models that are no longer deemed fit for purpose, like the United States Mask 1836, are still listed.

So what can you do if you want a quality N95 respirator? The simple answer is to buy respirators marked N95 from reputable retailers. If all else fails, 3M and Kimberly-Clark are quality suppliers of N95 masks.

More: New CDC study says valved respirators/masks do just as good of a job as basic masks

Unfortunately, buying masks from Amazon can be dicey, as it has been allowing sellers to falsely denote FDA approval for masks, leading Senator Elizabeth Warren to call for an investigation.

Armbrust identified the problem before Senator Warren and decided to perform their own testing of Amazon masks. Armbrust maintains a database of their findings, and while of course their own masks get top marks, the American-made DEMETECH ASTM Level 3 and Chinese-made Diolv 3 layer masks also score highly. You can subscribe to Ambrust’s YouTube channel to see their latest mask reviews. Unfortunately, Armbrust’s tests focus mostly on surgical masks and a few cloth masks, but no N95 respirators.