December 10, 2020 By danny.carvalho@ymail.com Off

KN95 and 3M N95 – Differences, Uses, and Performance Data

What are the differences between 3M N95 masks and KN95 masks? How do KN95 masks compare to 3M-N95 masks?

What is a KN95 Mask?

K9N5 masks are considered similar in filtration capabilities to N95 technology. However, one of the major differences is that most KN95 masks feature ear loops instead of head band protection.

Sometimes, ear loop designs are more desirable for less critical use, while only surgical grade N95 masks would be FDA approved for sterile medical procedures.

In the case of a pandemic, the ear loop design is desirable for quick donning and doffing (taking off and putting back on). However, in medical arenas where users are likely exposed to high levels of viral load, a tighter fit with less leakage is most beneficial.

Why Do KN95 Have Ear Loops Instead of Headbands?

Comfort and ease are the primary reason that KN95s frequently have ear loops instead of a headband design.

Pros and Cons of Ear Loop Facemask Designs

The ear loop design has significant advantages in more casual settings, as the ear loops are more comfortable, more durable, and easier to donn when wearing headgear, hats, or PPE such as helmets.

Pros and Cons of Headband Face Masks Designs

Headband designs maintain a more snug fit for the masks and prevent leakage, but will break when overstretched and are challenging to put on and take off for those with thick hair or certain hair styles.

The direct advantage of the headband straps is that the mask fits and forms closer to the face, thus less unfiltered air can enter from any gaps or seams around the edges of the mask.

3M N95 Masks

3M N95 masks are produced by 3M and select private label manufacturers. N95 masks are considered a gold standard for healthcare workers on the front lines, as the microporous material is able to filter 95% of particles at 0.3 micron. N95 mask materials have multiple grades, such as those rated sterile for surgical procedures, and also those rated for general purpose particulate filtration.

SARS-COVID-2 Virus Size

Viruses are small, some smaller than 0.1 micron. As noted above, if a mask only filters items as small as 0.3 micron, how does it filter viruses like SARS-COVID-2 as small as 0.1 micron? 

As far as Viruses go, SARS-COVID-2 has a rather large envelope for viruses at 50 – 200 nm ( 0.05 – 0.2 micron). Each virus may have 10^30 virions (virus particles). Exposure to a virus does not mean the virus will infect the host. The “viral load” is something that can measure the amount of virus present in a person by swabbing and testing their saliva or nasopharyngeal specimens.

Read: How Virus Droplet Size Affects Filtration and Infection Rates

Studies aim to better understand exactly “how much” virus material is required before a host becomes exposed. While the connection between severity of the virus and “viral load” found within the host appears inconclusive, data indicates that patients with higher initial viral loads were more likely to die and experience severe symptoms. The study below also finds that older age groups were associated with higher peak loads.

“Studies for SARS-CoV have shown that a high initial viral load was associated with death.22 However, our study only showed that the median viral load was 1 log10 higher in severe cases than in mild cases, and the difference was not significant. But, older age was associated with a higher peak viral load.” –

Lancet – Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study

There are many factors which determine the intensity, onset, and likeness of complications of various diseases or infections. 

Contagious spread is most likely in environments with high viral loads where static, unfiltered air is shared between passing hosts. In previous articles, studies argue that those not wearing masks were twice as likely to become infected by airborne virus particles. Meanwhile, an N95 mask could be up to 13X as effective as standard cloth masks in reducing infection and transmission rates.

Read: Why 3 Ply Face Masks and Surgical Masks are Meaningful N95 Mask Alternatives

N95 masks are rated for 95% capture of 0.3 micron particles. There are a number of mechanical and even electrostatic principles which will capture particles even smaller and prevent droplet-based virus particles from entering the lungs. Specifically, particles transmitted from person to person through the air.

The most important job of a face mask or face covering during a viral outbreak is to prevent infected individuals from further spreading germs from person-to-person.

“This respirator can help reduce inhalation exposures to certain airborne biological particles (e.g. mold, Bacillus anthracis, Mycobacterium tuberculosis, etc.) but cannot eliminate the risk of contracting infection, illness or disease. OSHA and other government agencies have not established safe exposure limits for these contaminants.” – 3M

FDA and HHS Face Mask Guidance

Masks for non-medical purposes are not medical devices and are not regulated by the FDA. For example, the term “surgical mask” is reserved for products designed and FDA approved for medical purposes.

Masks for medical purposes are regulated by the FDA. In the past months, the FDA has issued multiple updates on its approval of imported KN95 masks.

NIOSH-Approved N95 Particulate Filtering Facepiece Respirators

Emergency Use Authorization for Face Masks

“The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.” FDA – as of: 05/29/2020

On February 4, 2020, per  U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the HHS determined Coronavirus Disease 2019 (COVID-19 to be a public health emergency that could affect national security or the health and security of United States citizens living abroad. 

On March 2, 2020, circumstances justified the emergency authorization of personal respiratory protective devices during the COVID19) outbreak, subject to previous terms issues in Section.1

On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95s.

April 3, 2020: The FDA posted an FAQ answering whether respirators approved under standards used in other countries, such as KN95s, can be used in the US during the COVID-19 pandemic. The short answer is yes. In response to continued respirator shortages, the FDA also issued a new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.

On May 7, 2020, FDA revised and reissued the April 3, 2020 EUA based generally on concerns raised about the authenticity of certain respirators authorized under the third criterion of the April 3, 2020 EUA. For example, data from NIOSH testing on some respirators that were listed in Appendix A showed that the respirators failed to meet the expected filtration performance efficiency.

“This EUA does not affect the previous March 28, 2020, EUA for Non-NIOSH-Approved Imported FFRs (originally issued on March 24, 2020), which authorizes, in part, the emergency use of certain imported disposable FFRs that are not NIOSH-approved and excluded those manufactured in China…..”

The statement goes on to say, “FDA is re-issuing this EUA with certain revisions to authorize disposable respirators manufactured in China that meet certain criteria, including criteria concerning additional validation and review by FDA to confirm the respirator’s authenticity.”

Use of KN95 Masks for Healthcare Professionals – Is it Acceptable?

According to Oregon.gov, Michael Wood, administrator for Oregon OSHA states, “In such cases, medical personnel should only use KN95 respirators that are on the FDA’s approved list.”

KN95s can continue to be used as face coverings (similarly to the use of cloth, paper and disposable face coverings), but KN95s should not be used as respirators for healthcare professionals.

Strategies for Optimizing the Supply of N95 Respirators

KN95 Manufacturing Quality

There have been a number of issues related to manufacturing quality of KN95 and 3M N95 masks. Particularly, abusive practices such as counterfeiting, price gouging, false labeling, and unsubstantiated or non-applicable claims.

Mask Testing

The NIOSH has gone as far as testing masks from various manufacturers. Find the results here.

69% of the masks tested by the NIOSH in fact performed within claimed testing standards. 79% of samples fell within 10% of claimed filtration efficacy.

Of course, the sale of any PPE equipment which does not meet performance and testing standards is reason for concern. However, one must also note that the sample size tested is quite small and does not necessarily reflect expected performance of the aggregate.

NIOSH Face Mask Testing Results Analysis

We analyzed the NIOSH face mask testing results to evaluate how widespread “under performing” face masks were within the sample size.

Number of Masks Tested: 225
Number of Masks that Met 95% Filtration Efficacy Standards: 154 (69%)
Number of Masks Below 95% Filtration Efficacy: 71 (31.5%)
Masks Below 90% Filtration Efficacy: 53 (23.5%)
Masks Below 50% Filtration Efficacy: 17 (7.5%)
Average Filtration Efficacy of Sample Size: 89%

Assuming these test results are 100% accurate and reflect the actual quality of larger sample sizes, the vast majority of imported KN95 masks show nearly identical filtration efficacy when comparing KN95 masks to standard N95 particulate arresting masks. However, the filtration media is just one component of the overall performance of the mask.

How to Ensure Quality of Face Mask Purchases

One advantage of buying PPE, Facemasks, and sanitation chemicals from Production Automation Corporation (PAC – that’s us), is that we 100% stand behind each of 30,000+ products we sell online.

Our economical KN95 face masks are manufactured in an FDA-registered cleanroom production facility known for quality and consistency. The masks were tested and certified by an independent analysis of a third party to meet the minimum 95% particulate filtration standards.

We often help critical and general manufacturers outline a contamination control strategy. We’ll help you identify and maintain an end to end PPE supply chain without excessive phone calls and emails. Instead you’ll skip the wait times and get in-stock items ready to ship from our warehouses in Texas, California, and Minnesota.

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