Why you should purchase an N95 that's Made in the USA

Having a steady supply of N95 masks is probably one of the most unexpected expenses you have for the year 2020. Given that it can only be used once, or at least only a few times, you need to find an N95 mask that works for your budget. But, the market and the prices will not adjust just for you.


So you probably thought: Should I just get an N95 respirator somewhere else? How about the ones coming from China or Korea? Are those N95 respirators? In this article, we will discuss why you should only buy your supply of N95 respirators from sources within the United States. 


The Stringent Requirements

The answer is simple: N95 masks and N95 respirators undergo stringent and strict manufacturing processes to make sure that it passes through the standards. 


The United States is one of the most standard-strict countries. It does not just allow any product to come out of the production line without passing through the requirements that it has set for the protection of the end user. 


The Standards 

The standards that the N95 respirators go through in the United States is not a joke. Two federal agencies regulate the production and manufacturing of these personal protective equipment. There is the National Institute for Occupational Safety and Health (NIOSH) and there is also the Centers for Disease Control and Prevention (CDC). 


Both the NIOSH and the CDC recommend the use of an N95 respirator that is certified by NIOSH over and above any other mask. They recommend it for use of healthcare workers and those who come in direct contact with positive patients.


How Strict Are United States Standards?

The NIOSH established stringent rules in order for a manufacturer to even get considered for a certification.  They use the worst possible scenario parameters so that individuals could have peace of mind whenever they use the NIOSH face mask. From research, the following are the tests that an N95 respirator creator must comply with:

  • A sodium chloride (for N-series filters) or a dioctyl phthalate oil (for R- and P-series filters) test aerosol - the N95 mask must filter out with a mass median aerodynamic diameter particle of about 0.3 µm.
  • The Airflow rate must be at least 85 L/min. This represents a moderately-high work rate but it still allows the end-user to breathe freely while using the N95 mask.
  • The conditioning must be at 85% relative humidity and 38°C for 24 hours prior to testing.
  • The N95 respirator must also have an initial breathing resistance or a resistance to airflow that does not exceed 35 mm water column* height pressure and initial exhalation resistance not exceeding 25 mm water column height pressure.

The efficiency filter must not fall within any of the NIOSH certification class levels for the N95 mask to pass the requirements. Hence, N95 masks manufactured in the United States have great performance parameters, fiber diameters, and filter thickness like no other mask in the market, based on US standards.


To reiterate, the NIOSH standards for N95 masks are mostly set for the worst case scenario. If you have an N95 mask you are sure that it can withstand the scenarios that science have predicted. 


95% Respiratory Protection

One of the most important aspects of wearing an N95 respirator is the respiratory protection that it has to offer. The 95 in N95 masks represent the rating given based on the challenge aerosol that the mask captures. Generally, N95 respirators collect at least 95% of the challenge aerosol. 


Filters, on the other hand, are rated as N, R, or P. These letters represent the mask’s resistance to oil. N is the rating for those that are not resistant to oil, R is for masks that are somewhat resistant to oil, while P are strongly resistant. This system gives rise to nine types of particulate respirator filters, such as:


  • N95, N-99, and N-100;
  • R-95, R-99, and R-100; and 
  • P-95, P-99, and P-100.

The respiratory filters are tested by NIOSH to make sure that they continue to meet the certification test criteria. While the Food and Drug Administration (FDA) does not perform or evaluate any kind of filter test results, the NIOSH certification standards are enough. 


US Standards Fit Test

One of the more important things about the US-certified N95 masks is the fit test. There are two important design characteristics of the N95 respirator fit that individual masks should have: 

  • The respirator may operate in either a “negative pressure” or a “positive pressure” mode; and 
  • The type of facepiece and the level of coverage that it brings to the user’s face is important. 

Pressure Mode

For an N95 Respirator to fit the US standards it must work well in positive pressure. Negative pressure respirators offer less protection since inward leakage is possible. N95 respirators made in the United States work more on positive pressure over negative pressure. 


Face Coverage

Your N95 respirator must fit the NIOSH recommendation. The user must conduct an initial fit test to know if the mask is really something that works for his size. He should choose an N95 mask that really works for him and his needs.


There Is No Supply Problem

A common answer that people have as to why they do not buy N95 masks is not just the lack of budget but the depleting supply. However, everyone should know that the President of the United States signed the Defense Production Act (DPA) recently which ordered 3M to increase production of N95 respirators. 3M is the world’s largest manufacturer of N95 respirators and we can trust that they will provide and continue making supplies for us.

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