Are all N95 respirators Made in the USA?

The COVID-19 pandemic has increased the use of the N95 respirator. This type of disposable face mask offers the required protection against the coronavirus, and people started to buy them nonstop.

This essential personal protection equipment (PPE) piece is needed more and more in hospitals across the country, and many of these N95 respirators don’t say “made in the USA”. So, aren’t all N95 respirators made in the USA? In this article, we’ll talk about the importation of these masks. 

First, let’s start with the basics. The classification of N95 respirator is given by a United States institution, the National Institute for Occupational Safety and Health (NIOSH). This is a federal agency, part of the Centers for Disease Control and Prevention. Its job is to give recommendations and regulate all the PPE necessary to prevent work-related injuries or illnesses. 

NIOSH has a filtering rating for respirators. This classification gives each type of respirator a name according to certain features, especially the minimum filtration efficacy. So, to be called an N95 respirator, it must meet the criteria set by NIOSH for N95 masks. If it doesn’t have this approval, it can’t be used as an N95 respirator because it won’t be efficient. 

The names given by NIOSH indicate two specific features: first, a letter N, R, or P, indicating resistance to oil. Then a number that indicates the percentage of filtration. The N95 respirator, among other features, is not resistant to oil, and filtrates a minimum of 95% of all airborne particles in the air (those are particles of 0.3 micrometers in diameter).

So, to be called N95, the respirator has to meet the NIOSH standards and be certified or approved by them. Even though these are American standards, the masks can be manufactured outside the USA, but as long as they are approved by NIOSH, they can be called N95. There are different standards for respirators around the world. For example, in China the GB2626-2006 for KN95 respirators, and in Europe, they have EN 149:2001+A1:2009.

 

Are KN95 and N95 masks the same?

As we explained above, there are different standards for respirators around the world. China has specific guidelines to meet, just like the ones established by NIOSH. In China, these standards are the GB2626-2006, and the product is the KN95 mask. Therefore, the main difference between these two is the standards they meet. For this reason, KN95 masks are typically manufactured in China and not the United States. 

However, the similar names come from similarities in their functionality. Just like N95 masks, KN95 respirators filtrate 95% of airborne particles, and are not resistant to oil. Differences come from other types of features under their respective criteria, like breathability or the obligation to do fit-testing.

 

Manufacturing N95 masks outside the USA

Many companies have manufacturing factories outside the USA and import them into the country. For example, 3M, which is probably the most important medical PPE manufacturer in the US. 3M is an American company that specializes in work-related safety, in particular medical, surgical, and dental PPE. 

3M actually developed the prototype for the N95 mask back in 1972 and has since been one of the most important suppliers of this item in the United States and around the world. Even though they have factories in many countries, including China, 3M products sold in the US tend to be made in the US. According to them, they focus on manufacturing products close to where they sell them. 

Nevertheless, N95 masks can be imported from factories outside the USA, but they have to meet certain requirements. For example, N95 respirators intended for medical use need to be regulated by the Food and Drug Administration (FDA). For use by other work fields, the Occupational Safety and Health Administration (OSHA). You can see the complete list of importation requirements here. 

 

The emergency umbrella authorization by the FDA

Now, we are in a special situation, and out of the ordinary measures have been taken in regards to N95 respirators that are being imported. On April 3, 2020, the FDA issued what is known as an umbrella emergency authorization (EUA) for a number of disposable face masks produced outside of the United States, that weren’t previously approved by the NIOSH, including N95 and KN95 respirators.

These products were evaluated by the FDA to meet the criteria to fit under the EUA rules. Unfortunately, further evaluation done in May by the FDA and the CDC/NIOSH concluded that many of these respirators weren’t meeting the filtration standards to be considered N95 respirators. 

On May 7, 2020, the FDA revised and reissued the EUA to include only respirators that met the filtration standards. They also, along with the NIOSH, increased their surveillance and sampling of all the respirators coming from China primarily. 

This error led to the import of millions of low-quality respirators, among which only about 60% met the filtration standards, between April and May. However, the quick update on their EUA guidelines promises to ensure only true N95 respirators will enter the country. 

Remember to protect your family and kids with the best N95 respirators. They are available for purchase in many online stores and at a good price, where you can shop while practicing social distance. This way you’ll be ensuring the safety of your community while protecting yourself and the ones you love at the same time. 

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