N95 respiratory face masks are considered to be probably the best currently available option for personal protective equipment against the COVID-19.
The CDC, NIOSH, and OSHA, alongside the World Health organization, all recommend we wear masks as protective equipment but say that N95 masks should be reserved for the health staff and first responders.
However, if you do come across an N95 mask and have a chance to buy it, these disease control administrations and centers surely recommend you do so.
But, before you go out and try to find yourself an N95 mask, maybe you should first learn about some of its features, characteristics, and purpose. In the following paragraphs, we’ll tackle some of the most frequently asked questions regarding N95 masks. So, let’s get started!
N95 Mask: Quick Summary
- N95 masks are regulated respirator face masks designed to protect from airborne particles.
- N95 masks are regulated by the FDA, as well as by NIOSH under the regulatory collaboration of FDA and NIOSH.
- N95 masks provide at least 95% protection against airborne particles, bacteria, viruses, bodily fluids, etc.
- N95 masks have a unique, airtight seal fit and design that feature headbands, and tight-fitting nosepiece.
- N95 masks are recommended to be used by health care providers and first responders but can be used by the general public as well.
- N95 masks can be used as protective equipment during the ongoing COVID-19 pandemic.
- N95 masks can be used and reused up to 5 times according to NIOSH.
1. What Does N95 Mask Stand For?
N95 mask stands for a respiratory protective device designed to protect the wearer from airborne particles through efficient filtration. Surgical N95 respirators are used in healthcare settings and are a subset of N95 filtering facepiece respirators.
Most N95 respirator masks are designed for construction or industrial type jobs, as well as during health care procedures. However, as of recently, N95 masks are used as disposable respiratory protective devices in a general health care setting and by the general public.
N95 masks are considered to be the functional equivalent to certain respiratory devices that are not under the regulation of US jurisdiction. These masks are the equivalent to FFP2 respirator masks from the European Union or the KN95 masks that are regulated by China.
2. How Are N95 Masks Regulated?
According to FDA, N95 respirator masks are regulated by the FDA as class II devices, under 21 CFR 878.4040, and CDC NIOSH under CFR Part 84 regulation.
They are also regulated under product code MSH. The FDA has a Memorandum of Understanding with NIOSH that outlines the regulatory collaboration between the FDA and NIOSH regarding the regulation of N95 respiratory masks.
3. How Are N95 Masks Tested?
N95 masks are tested and approved by NIOSH and FDA, as well as CDC and other federal agencies and health organizations. These masks are tested for fluid resistance, filtration efficiency (particulate and bacteria filtration efficiency), biocompatibility, and flammability.
For masks like FFPs or KN95, there are slightly different testing criteria to determine performance and efficiency, for example, test agent and flow rate, or permissible pressure drop (resistance to fluid flow and fluid velocity).
4. What Do N95 Masks Protect From?
An N95 respirator mask is designed to protect from specific diseases and infections. Its filtration ability is supposed to also protect from airborne particles, viruses, bacteria, microorganisms, liquid droplets (from coughing and sneezing), etc.
It is also supposed to protect from pollution, allergens, and generally particles that are greater than 0.3 µm in diameter. N95 respirator masks have more or less 95% protection efficiency against all of the aforementioned airborne particles.
5. What Are N95 Masks Made From?
N95 masks are made from a fine mesh of synthetic polymer fibers, or to be more specific, from nonwoven polypropylene fabric.
These fibers are plastic and are used to make synthetic and polyester shirts, jackets, yoga pants, and other clothing items that people wear around the world. These masks are produced by melt blowing. Here’s a more specific insight into the materials of the N95 masks;
- Straps of the N95 masks are made from polyisoprene (natural rubber).
- Staples of the mask are made from steel.
- The nose foam in the mask is made from polyurethane (known as PUR foam, used for insulation of fridges and freezers, for building insulation or as cushioning for furniture).
- The filter, valve, and valve diaphragm are made from nonwoven polypropylene fabric.
6. What Types Of N95 Masks Are There?
- Standard N95 Respirator Mask – the standard N95 mask is widely available and recommended as protective equipment against airborne particles (bacteria, viruses, dust, fumes, fibers, etc.). It meets the NIOSH requirements and standards for minimum filtration efficiency of 95%, against solid and liquid, non-oil aerosols. This mask is not made with natural rubber latex and is not FDA-cleared as a surgical mask. However, the standard N95 mask is not fluid-resistant according to the ASTM Test Method F1862 ‘Resistance of Medical Face Masks to Penetration by Synthetic Blood’.
- Surgical N95 Respirator Mask – just like the standard N95 mask, the surgical one is also recommended as protective equipment against airborne particles. It also meets all the NIOSH standards and requirements for filtration efficiency and is cleared by the FDA as a surgical mask. The mask is not made with natural rubber latex and is fluid-resistant under varying high pressures. The 3M Company produces FDA-cleared N95 surgical masks, so there are two models; the Model 1860 and the Model 1870+.
- N95 Mask With Exhalation Valve – alongside the standard N95 masks, there are also N95 masks with exhalation valves. According to the CDC, respirator masks with exhalation valves can protect the wearer from airborne particles and viruses like COVID-19. However, they may not prevent the virus from spreading to other people, so these masks are NOT effective for source control. The CDC advises we DO NOT wear masks with exhalation valves, because both source control and respiratory protection are required for the current situation.
7. How Does N95 Mask Fit?
N95 mask has a tight-fitting, face seal fit. The edges of the N95 respirator mask are designed to form a seal around the nose and the mouth. The headbands are there to further ensure a proper, airtight seal and fit. N95 mask can be put on fast and easy, and when put on properly, it prevents airborne particles from entering your airway and respiratory system.
Note: A respirator mask cannot protect you if it doesn’t fit properly to your face! So, always make sure your N95 mask fits tightly around your face and that it has a tight seal in the nose and mouth area.
8. Are N95 Masks Efficient?
According to studies and NIOSH certifications, N95 respirator masks have a collection efficiency of at least 95% when tested against airborne and non-oil particles.
However, the filter penetration of the mask is significantly affected by the particle size and the breathing rate. These masks, as mentioned, are only effective in the absence of oil particles, such as cutting fluids, lubricants, and glycerine. They are also not effective in cases of fire (firefighting), in oxygen-deficient areas, facilities, or surroundings, as well as in cases of hazardous gases or vapors.
N95 masks are proven to be efficient is health care settings, against airborne particles, viruses, bacteria, fungi, etc. The masks can provide proper respiratory protection against infectious particles.
So far, they have proven effective in cases of avian influenza, severe acute respiratory syndrome (SARS), pandemic influenza, tuberculosis, and Ebola. However, there are currently NOT enough studies to evaluate the effectiveness of the N95 masks in regards to Coronavirus.
9. Does The WHO Recommend N95 Masks Against COVID-19?
According to the WHO, wearing N95 masks results in the reduction of infection among health workers, so N95 and similar masks can be associated with a reduction of risk in COVID-19 transmission.
So far, N95 masks have proven effective in influenza-like illnesses, clinical-respiratory illnesses, and viral infections. However, the WHO has also announced new guidelines regarding who and where should wear a mask during the COVID-19 pandemic.
The WHO and CDC as well recommend that the general public wear cloth masks that have at least 3 layers, while N95, KN95, and surgical masks are reserved for health care workers and first responders.
Also on June 3rd at the WHO press conference, it has been stated that masks should be used for purposes of source control, so cloth masks should do just fine for people who may be infectious, but asymptomatic.
N95 masks are to be used by health care providers and first responders, but if members of the general public wear these masks, they can expect certain-degree protection against the virus.
10. Are N95 Masks Reusable?
N95 respiratory masks can be used beyond their designated shelf life. They can also be reused a limited number of times after being removed, according to the CDC. NIOSH also recommends that during shortages, N95 masks can be used up to 5 times without cleaning the mask.
However, this only applies to cases where there is no physical damage to a mask, no signs of the mask degrading, and if the mask hasn’t been exposed to bodily fluids or exposed to a patient during aerosol-generating procedures.
So, if you want to wear your N95 mask more than one time, just make sure to store it properly, avoid touching it and make sure it is put away from the reach of other people and children.
Make sure not to touch the mask as you’re wearing it, to avoid self-contamination. If you’ve been exposed to other peoples’ sneezing, coughing, or bodily fluids, do not reuse the mask; instead, put it in a plastic bag and dispose of it in the trash.
11. Can N95 Masks Be Decontaminated?
Masks like N95 are currently not approved for routine decontamination as a standard of care.
However, decontamination, just like new concepts of reuse, is considered as a part of crisis strategy for the ongoing COVID-19 pandemic. This is considered to be enough to ensure continued availability of N95 masks for health care providers and first responders.
OSHA doesn’t currently have any standards for N95 disinfection. NIOSH recommends we use these masks up to 5 times, without the need to disinfect or clean them.
According to the CDC, however, decontamination methods like moist heat, ultraviolet germicidal irradiation, and vaporous hydrogen peroxide seem to be the most promising ones when it comes to N95 masks.
12. How To identify A Fake N95 Mask?
According to the latest guidance from The National Personal Protective Technology Laboratory (NPPTL), here’s how you can tell if your N95 mask is real or fake;
- Earloops vs. Headbands – NIOSH-approved N95 masks have headbands, which ensure a tighter fit of the mask. Counterfit N95 masks have ear loops.
- NIOSH approval label – all NIOSH-approved N95 masks feature an approval label on the packaging. Sometimes, the label is within the user instructions. If you don’t have the mask packaging, check if the mask itself has the approval abbreviation; a real N95 mask should have an abbreviation approval sign.
- Facepiece markings – a real N95 mask should have NIOSH facepiece markings or approval numbers on the mask or the headband.
- Misspelling – counterfeit N95 masks often have NIOSH label misspelled; the most common variation is ‘NOISH’.
- Decorations – counterfeit N95 masks often have decorative fabrics and add-ons (usually sequins). Real N95 masks do not contain any such decorations or additional fabric.
- Approved for use by children – no respirator face mask is approved for use by children. That is how you can tell if your N95 mask is fake; if it’s approved for use by children, do not buy or use the mask.
13. What Are The Downsides To N95 Masks?
- Breathing difficulties – N95 masks can cause breathing difficulties in people with chronic respiratory, cardiac, or other medical conditions. They can also cause oxygen shortage in these patients, so they should be careful when wearing the N95 masks, especially if they’re wearing the mask for several hours.
- Increased heart rate – studies have shown that during the SARS outbreak, N95 masks increased the heart rate, alongside the breathing difficulties and increased stress levels. A shortage of oxygen stimulates the sympathetic nervous system and increases the heart rate, which causes further conditions like fatigue or general discomfort.
- Thermal stress – N95 masks have also shown to increase skin temperature, humidity, and increased microclimate temperature, which eventually affects the breathing ability and heart rate. This can result in general discomfort, nervousness, irritability, increased stress levels, fatigue, etc.
- Skin issues – because N95 masks fit so tightly around the face, they can cause serious skin irritation and itchiness. This results in general discomfort, increased stress because of the itchiness and irritation, and further skin issues if the irritation is not treated, or if it’s recurring.
14. Where Can I Buy A Proper N95 Mask?
We are not going to feature any of the N95 sellers this time, and again we suggest you leave it to health care providers and first responders.
However, if you do come across a brand or seller of N95 masks, and you’re not sure whether they’re selling FDA-cleared N95 masks, make sure to check the FDA list of authorized importers and manufacturers of respiratory masks as well as the database for Establishment Registration and Device Listing.
Here, you can simply type in the name of the company, seller, or brand of the N95 masks and see if they’re FDA-cleared sellers, providers or manufacturers.