Were KN95 Masks Recalled?

It was very apparent during the early weeks of COVID-19 that critical personal protective items, like N95 masks, would be in short supply. While we took action to get necessary supplies to frontline healthcare workers, the general public was instructed by the CDC and FDA not to wear these masks so that the supplies that remained could be reserved for medical personnel.

Even with these measures in place, it was necessary to find other means of protecting our healthcare workers. Hospitals were overrun, and employees were working around the clock, many with no personal protective equipment at all, or with very limited, or even reused equipment. 

The situation became critical, and something had to be done. These events resulted in the FDA issuing an emergency use authorization for KN95 masks by healthcare workers. This effectively allowed masks that meet Chinese respiratory mask standards, known as KN95, to be used by American healthcare workers if they could not get access to a standard N95 mask.

The emergency use authorization did not provide that the KN95 mask would be a substitute for the N95 for healthcare workers, but did put more personal protective equipment into the hands of frontline workers to help them keep safe.

Once supply caught up with demand, KN95 masks were made available to the general public, as an option for individuals who would wear an N95 mask, but chose not to do so, leaving those supplies for healthcare workers. 

The KN95 is a great mask but you should know there are some businesses that sell counterfeits. There have also been a few instances where certain KN95 masks from specific manufacturers did not meet FDA standards. 

Hope Health Supply offers high quality KN95 masks, and other important personal protective items to help keep you and your loved ones safe during COVID-19. As such, we can help you better understand the KN95, and give you the information on what was actually recalled in 2020.

What Are KN95 Masks?

KN95 masks are masks that meet respirator standards in China. In the United States, masks that meet respiratory standards are the N95 masks. 

Each country has their own guidelines that govern their respirator masks, but it’s important to make sure that if you purchase a mask from another country you purchase one that is registered with the FDA and one that meets the CDC’s general mask guidelines. 

KN95 masks are typically made from a polyester blended material, feature an adjustable metal nose bridge, and attach to the wearer’s face by means of elastic ear loops. They are:

  • Breathable. Although KN95 masks offer some of the highest levels of filtration available, they remain breathable so the wearer is comfortable.
  • Effective. KN95 masks are capable of filtering up to 95% of non-oily suspended particles of 0.3 micron levels.
  • Preventative. Able to help prevent the spread of germs and protect the wearer from airborne particles, pollen, and other allergens. 

KN95 masks do not meet the same specification requirements as N95 masks, which is why it is preferable to have those in the medical profession use an N95 mask. Despite the differences, however, a KN95 mask is still incredibly effective, and can be expected to perform similarly to  an N95 mask.

Were KN95 Masks Recalled?

Yes and no. The FDA issued the emergency use authorization in April of 2020 allowing for the usage of KN95 masks by healthcare workers, however after testing some of the KN95 masks that were being used, the FDA decided to recall the emergency use authorization stating that some of the masks did not meet proper respiratory requirements. 

This “recall” also applied to the decontamination and reusability of these masks. It was determined that some KN95 masks did not retain the proper level of filtration after they had been decontaminated for reuse. 

In October, the recall was lifted, and the FDA now has a list of approved, registered KN95 manufacturers. When you consider purchasing a KN95 mask for yourself, you can cross-reference the retailer’s manufacturer with this list to make sure the mask you are buying is safe for use.

How Can You Know For Sure Your KN95 is Safe?

The best way to make sure that your KN95 mask is safe is for you to find out the manufacturer name and model information, so that you can cross-reference it with the FDA’s approved KN95 manufacturer list. If your retailer does not provide that information, or is unwilling to release it, you may want to reconsider purchasing a mask from them. 

It’s also very important to trust your retailer when purchasing any type of personal protective equipment. Read customer reviews, educate yourself on the specifications of the products they offer, and ensure that the business is reputable before you give them any credit card information or make a purchase. 

At Hope Health Supply, we only offer KN95 masks that are registered with the FDA and crafted to the highest in industry standards. We are completely transparent with our KN95 manufacturer information, and the FDA registration for our masks is found here

We’re serious about providing high quality personal protective supplies possible, and committed to staying reliable and affordable. 

Common KN95 Mask Questions

Maybe you’ve still got some questions. We understand. Navigating the pandemic world is tricky, and you want to be sure you’re wearing the most effective mask possible. 

Here are some of the most commonly asked KN95 questions:

  1. Is it a good idea to use KN95 masks against COVID-19? Using a KN95 mask is a great way to help slow the spread of COVID-19. The KN95 masks sold by Hope Health Supply meet CDC guidelines for mask-wearing and provide excellent filtration for the wearer. 

  2. Can I clean and reuse my KN95 mask? These masks are intended for single use. They are not machine washable. The decision to extend the use of your KN95 mask is solely at your discretion. 

  3. What should I do if I accidentally touch my KN95 mask? Wash or sanitize your hands if you touch your mask by accident. The real danger in touching your mask is the possible spread of bacteria and germs to your hands, so sanitizing or washing them should give you peace of mind. 

KN95 masks are efficient in helping slow the spread of the virus that causes COVID-19. Although the FDA found some KN95 masks did not provide the level of filtration needed to be worn by medical professionals, they did create a list of KN95 mask manufacturers that can be trusted. 

When you purchase a KN95 mask, make sure the mask manufacturer is on the FDA’s approved list and you can know the mask you are buying is safe and effective for use. 

You can get a high-quality, effective, FDA registered KN95 mask from Hope Health Supply. In addition to supplying you with a great mask, we will also donate one to a hospital in need every time you make a purchase. Peace of mind, and making a contribution to frontline workers is a great way to practice the personal responsibility of being “all in this together.” 

 

Sources:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/international-respirator-purchase.html?permalink=E6F92171F8C83EEE2FF60C5BF2DE3492A6D2398815B86DFDD15E4FADF7EB8504

https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter#1

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas