What does the FDA say about N95 Masks with Valves Filtration?


N95 masks are personal protective equipment commonly used to protect users from airborne particles and prevent their faces from getting contaminated by liquid. They are called N95 because they are a respiratory protective device designed to filter out 95% of 0.3-micron particles. With this, they can be referred to as one of the safest options when considering getting a face mask. The edges of N95 masks are designed to form a seal around the mouth and nose.  However, the respiratory valve on them is considered a problem. Different regulatory bodies have a lot to say about this specific problem. Some of the notable ones are Food and Drug Administration (FDA), the Centers for Disease Control and Prevention ( CDC), National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration( OSHA). Based on the focus of this article, the concentration will be placed on the FDA. 

What are the General N95 Respirator Precautions?

There are different things you should know before or when using the N95 respirators. These are very important because they determine your safety in one way or the other. Some of these precautions you are expected to take include:

  • N95 respirators must be cautiously used: It's very pertinent to know that N95 masks are not protective equipment that can be used carelessly by everyone. In fact, there are some individuals that are strictly advised to be cautious with the use of these face masks. Those suffering from medical conditions ( especially chronic respiratory and cardiac) that can make breathing difficult are expected to see their health care provider before going ahead to purchase and use an N95 respirator. The reason behind this is that the N95 masks can make breathing more difficult for the users.
  • Know when to use and when not to use the N95 respirators with exhalation valves: There see some models of N95 masks that are designed with exhalation valves to make exhaling air very easy and to help lower the build-up of heat. Nonetheless, these kinds of N95 respirators should be avoided when sterile conditions are needed.
  • Know the proper time to discard the N95 respirators: If you check the label on all FDA-cleared N95 respirators, you will see that they are disposable devices that should be used once. So, if you discover that your face mask is soiled, damaged, or makes breathing difficult, it should be removed, discarded properly, and replaced with a new one. The proper way of discarding your N95 masks is to put them in a plastic bag and drop it in the trash. Besides, ensure that you wash your hands after discarding them.
  • Restrictions: Some individuals are supposed to stay ways from the use of the N95 respirators. These include children and those with facial hair— N95 masks are not designed for them. This is because there is no way  N95 respirators can achieve a proper fit on them and possibly not provide full protection.

What is an Exhalation Valve on N95 Masks?

An exhalation valve is a small coin size disc on N95 masks ( on the side or center) to improve the wearer's comfort by reducing filtration resistance while breathing out. In order words, they help users to breathe easily by allowing the outflowing of air and preventing the humidity inside.

Several individuals will claim that face masks with breathing valves are better options than plain cloth covering when looking for a facial protective device. However, this claim is debatable because masks with breathing valves fail to prevent the transmission of coronavirus the same way simple masks can prevent it.

Are N95 Masks with Valve Filtration Good for you?

According to John O’Horo (a Mayo Clinic infectious disease doctor who heads up the institution’s Personal Protective Equipment Task Force), “The purpose of the valve is, when you exhale, it opens up to allow for carbon dioxide and expelled air to just exit the mask." However, there is a larger issue with respiratory valves— they are one-way filters. This implies that they don't filter exhaled air but only the air that comes inside the mask. This is a great risk, especially during the COVID-19 pandemic. In addition, Dr. Ali Raja, executive vice-chair of the department of emergency medicine at Massachusetts General Hospital and an associate professor at Harvard Medical School avers that “Any mask with a one-way valve is only going to protect the person wearing it. It won’t protect anyone around that person from potential exposure to virus particles they exhale,”

FDA notes that “Those are critical supplies that must continue to be reserved for health care workers and other medical first responders, as recommended by current CDC guidance." So, they are used by medical professionals in hospitals with other personal protection equipment that goes over the face. However, they are not supposed to be worn to accomplish" source control".

Furthermore, even though N95 masks are seen as safe protective equipment, some are still viable because of the presence of an exhalation valve. FDA while reissuing the Emergency Use Authorizations (EUAs) clearly stated that "only authorize decontamination of non-cellulose respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to be decontaminated."


In a nutshell, the FDA takes seriously the information of non-NIOSH approved respirators to be sure that health care personnel are well protected. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected", says Dr. Anand Shah, deputy commissioner for medical and scientific affairs at the FDA. The use of N98 masks with one-way valves do not comply with the orders given by the FDA.  You should know that one of the things that can make the virus keep spreading is allowing mostly unfiltered exhalations into the air.

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