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 continues to spread across the United States. With cases rising again and new concerns about airborne transmission, public health officials are once again urging people to wear masks in indoor spaces. But this time, the rules have changed—and not just in terms of who needs to wear them. The federal government has updated its guidelines on what types of masks are considered effective, raising the bar for acceptable protection. While The Prepared has long advised mask use since early 2020, we’re now seeing a shift toward more stringent standards. This means that not all masks are created equal anymore, and it’s important to know what to look for when you’re shopping for a new one. More: Best gas masks and respirators for survival If you’ve been wearing whatever you could find—whether it’s a cloth mask, a surgical mask, or a KN95—you might be wondering if it’s still up to the task. Here’s the latest on what the FDA and CDC are saying, and how it affects your choices.
  • The FDA has revoked Emergency Use Authorization (EUA) for KN95 masks and reused or decontaminated respirators.
  • Respirators, especially N95s, remain the gold standard for blocking airborne particles.
  • While N95s are U.S.-certified, many KN95s from China have been found to have inconsistent quality.
  • Only masks approved by NIOSH (part of the CDC) are currently considered safe for use.
  • NIOSH is also updating its standards, which may lead to some products being pulled from the market.
  • Buying from trusted brands like 3M or Kimberly-Clark is a safer bet.
  • Some local manufacturers, like Armbrust in Texas, are testing masks and publishing their results online.
  • Two models they recommend are the DEMETECH ASTM Level 3 and Diolv 3-layer masks.
### A Quick Guide to Respirator Standards Respirators offer the best protection against airborne viruses because they filter out about 95% of small particles. Different countries have their own certification systems: - **U.S.:** N95 - **China:** KN95 - **South Korea:** KF94 - **Japan:** DS2 - **Europe:** FFP2 In the U.S., N95s and KN95s are the most common. However, the quality of KN95s has been questionable, with many failing to meet U.S. standards. That’s why the FDA no longer recommends them, even though they’re still available online. ### The FDA Is Raising the Bar Last year, I warned against using KN95s due to unclear FDA guidelines. Now, with better supply chains, the agency is tightening its rules. They’ve stopped approving imported respirators and reusable ones, citing improved access to domestic N95s. The FDA stated: “As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies.” This means that only NIOSH-approved respirators should be used, and many previously accepted models are now off the table. ### New NIOSH Standards In June, NIOSH introduced stricter performance standards called Workplace Performance and Workplace Performance Plus. These require masks to fit snugly, be made of non-irritating materials, and pass leakage tests. Higher numbers mean better protection. These changes may help consumers identify better masks in the long run, but in the short term, it could make finding N95s more difficult. ### How Manufacturers Are Responding Small companies like United States Mask in Dallas are struggling to keep up with the new regulations. Their popular 1836 model was NIOSH-certified under emergency use, but now it’s no longer available. They’re working on a new design, but in the meantime, they’re selling existing stock at a discount. Another Texas-based company, Armbrust, is taking a different approach. They’re selling an AA-95 mask without claiming NIOSH approval, which is a bold move but highlights the uncertainty around current standards. ### Finding Quality Masks in a Confusing Market Despite the confusion, there are still reliable options. Stick to NIOSH-approved N95s from trusted retailers. Brands like 3M and Kimberly-Clark are good choices. Avoid Amazon unless you’re certain about the product’s authenticity—some sellers falsely claim FDA approval. Armbrust’s independent testing of masks, including the DEMETECH and Diolv models, can also be a helpful resource. Just remember that their tests focus more on surgical masks than N95s. With so much changing so quickly, it’s easy to feel lost. But staying informed and sticking to certified products is your best defense.

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