Mask mandates are making a comeback, even for vaccinated individuals, as the Delta variant spreads rapidly across the U.S. With rising cases and new public health concerns, many cities and states have reintroduced mask requirements—sometimes even for those who’ve received their shots.
As these rules come back into play, the federal government has also updated its guidelines on which masks are considered safe and effective. The Prepared has long advised on mask use since early 2020, and while our original recommendations still hold, we’re now updating you on the latest standards and what they mean for your choices in the mask market.
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If you've been skipping masks altogether or just grabbing whatever is available when required, it's time to take a closer look at what’s actually effective. Here’s what you need to know:
- The FDA has revoked its Emergency Use Authorization (EUA) for KN95 masks and reused or decontaminated masks.
- Respirators remain the most effective protection against airborne viruses.
- The most common types in the U.S. are N95s from American manufacturers and KN95s from China.
- While the EUA was initially for healthcare workers, it supported our earlier advice to avoid KN95s due to inconsistent quality.
- Only masks approved by the CDC’s NIOSH division are considered reliable, but NIOSH has raised its standards, removing some products from the market.
- Your best bet is to buy authentic N95 respirators from trusted retailers.
- Brands like 3M and Kimberly-Clark are reliable choices.
- Texas-based manufacturer Armbrust has tested surgical masks from Amazon and maintains a database of their performance.
- Two masks they recommend are the American-made DEMETECH ASTM Level 3 and the Chinese-made Diolv 3-layer mask.
### A quick rundown on respirator standards
We previously covered the differences between respirator types, but here’s a quick summary: Respirators offer the highest level of protection against airborne pathogens by filtering out about 95% of particles. Different countries have their own standards:
- **United States:** N95
- **China:** KN95
- **South Korea:** KF94
- **Japan:** DS2
- **Europe:** FFP2
In the U.S., N95s and KN95s are the most common. However, during the early days of the pandemic, many low-quality masks flooded the market, especially from China. While healthcare workers are no longer allowed to use KN95s, they’re still sold online. But with the FDA no longer extending EUAs for these masks, it’s clear that the U.S. government doesn’t trust them anymore.
### The FDA raises the bar on masks
The CDC isn’t the only agency changing its stance on masks. Last year, I warned against using KN95s due to unclear FDA guidelines. Now that supply chains have stabilized, the FDA is tightening regulations. It has revoked EUAs for imported respirators and reused masks.
In a June 30 statement, the FDA said:
> "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."
These authorizations were issued during the early pandemic when PPE was scarce. Now, with more reliable options available, the FDA believes it’s time to move away from less effective alternatives.
NIOSH, part of the CDC, has also raised its standards, requiring manufacturers to meet new criteria. This means some older models may no longer be approved.
### The new NIOSH standards
In June, NIOSH introduced new standards called Workplace Performance and Workplace Performance Plus. To qualify, masks must meet specific design and safety criteria, including:
- A snug fit around the nose and face
- Materials that don’t irritate the skin
- Either disposable or reusable
- Suitable for a range of face shapes
- A leakage ratio of at least 5 (for Workplace Performance) or 10 (for Workplace Performance Plus)
While these changes aim to improve quality, they may make it harder to find certain N95 masks in the short term.
### How manufacturers are responding
Many companies are adjusting to the new rules. For example, United States Mask, a small Dallas-based company, had to stop producing its popular 1836 N95 model because it was only approved under the old emergency authorization. They’re now working on a new version and selling existing stock at a discount.
Another Texas company, Armbrust, is taking a different approach. It’s selling its AA-95 mask without claiming it’s NIOSH-approved, acknowledging the current regulatory uncertainty.
### Cutting through the confusion
Since the start of the pandemic, I’ve recommended sticking to government-approved masks. But the guidelines can be confusing. While the NIOSH list is helpful, some outdated models are still listed.
So, how do you find a quality N95? Stick to reputable retailers and brands like 3M or Kimberly-Clark. Avoid Amazon if possible, as it’s been criticized for allowing fake FDA approvals.
Armbrust’s testing of Amazon masks shows that some surgical masks, like the DEMETECH and Diolv, perform well. You can check their YouTube channel for more reviews.
Ultimately, the best way to stay protected is to choose NIOSH-approved N95 respirators from trusted sources. Stay informed, stay safe.
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