What is an M95 and how does it compare to N95 or KN95?
It’s difficult to sift through all the misinformation about the proper masks that should be worn and what products meet the U.S. standards that we have come to expect. We have heard claims that our engineered M-Series products are counterfeit or that our products are part of a non-existent category of masks.
A common question people have asked is what is an M95i or M95c mask and how does it compare to a NIOSH Certified N95 or even the Chinese Standard KN95 GB2626-2006 or GB2626-2019?
- N95 – NIOSH Certified respirator with dual straps that wrap around the head. Made in US, Mexico, or China. One size fits all.
- KN95 – Chinese standard masks with ear loops or dual head straps. Made in China. One size fits all.
- M95i – Lutema by MI Technologies, Inc. international standard size respirator - with ear loops. American made. Meets the U.S. filtration standards for ASTM Level 3, NIOSH N95 Respirators, and K95 Chinese Standard
- M95c – Lutema by MI Technologies, Inc. compact size respirator - with ear loops. American made. Meets the U.S. filtration standards for ASTM Level 3, NIOSH N95 Respirators, and K95 Chinese Standard
- M94k – Lutema by MI Technologies, Inc. extra small size respirator - with ear loops. American made with high filtration for toddlers to age 6.
I wanted to take a minute to explain the differences between an N95, a KN95, and what we engineered and called our M-Series products and why we named our first iteration an M95i.
Where we started and why?
We started this journey in Q1 of 2020 in the midst of news coming out about a potential new virus. We began to search for a better, more protective, more comfortable, and a more fashionable mask. Just like many fellow Americans, it was nearly impossible to find a product that met the needs of our families. We started by sourcing masks from China, Korea, India, Vietnam and Japan. Sale after sale, review after review, we found that the products we were sourcing had major shortcomings. None of them met what we would call the ideal mask. Far too many were flimsy, inconsistent, dirty, and 50% of the earloop elastics would snap off before we got them out of the box! The remaining 50% snapped when you pulled the mask down to scratch your nose from the uncomfortable inner liner of the mask! We became weary and started to test these masks for filtration levels. Some batches would pass and many others would fail. Inconsistency in raw materials, production lots, and quality control was driving us nuts. The researchers at ECRI found that 70% percent of imported KN95 masks did not filter 95% of aerosol particulates, the basis for the very name of the product.
Videos online started to surface about the working conditions of asia-based factories, concerns about hygiene and the way the masks were handled before they were placed into a beautiful color box to be shipped to our country.
We decided to manufacture our own masks with our own American Standards in mind. Masks that were consistently comfortable, protective, and fashionable for the whole family. Our goal was very customer-centric and we were seeking to make products that met the needs of our fellow Americans in a clean and automated fashion. We had to move quickly in the middle of an out-of-control pandemic and we did just that!
We reached out to the CDC, NIOSH, and FDA to gain certification for our masks. We succeeded with the FDA Registration (3017171515) and FDA Listing (692452) process under a new business entity called Breathh, Inc. (10076872). A business setup specifically to manufacture respirators and face masks during the Covid19 pandemic.
Why not N95?
In order to receive the “N95” labeling from NIOSH, mask manufacturers need to meet strict filtration standards and have a dual elastic band that wraps around the user’s head in order to ensure a complete seal around the chin, mouth and nose. This category is used for professions such as medical professionals and firefighters who are exposed to toxins and airborne diseases to a greater extent than the general public. Our customers desired a comfortable and fashionable option that still met the strict U.S. filtration standards and we refused to get a certification just to check a box required to advertise our masks as an N95.
The world has changed quickly and we can’t expect legacy manufacturers, such as 3M, to be able to change quickly with the times. The same way we would not expect Ford to go electric without the threat and innovation from a company like Tesla. Although they are both great American companies, the latter forces the legacy company to innovate or risk losing its customers.
Why not KN95?
We further refused to call our product a KN95 based on a Chinese Standard or to risk it getting mixed up with hoards of sub-par products hitting America's docks and Airports from overseas. Most of which failed claimed filtration requirements for the KN95 or N95 labeling. This could be blamed on foreign companies for counterfeiting or just a pure lack of control from the GB2626 Certification body to control the sub-par products it has been exporting. It may have been as simple as a bad actors' blatant effort to sell sub-par quality products to countries who were desperate. Because of these issues, we refused to put the KN95 or GB2626 labeling on our products. If we simply wanted to choose the easy road to profit - we would have kept importing goods like all those sellers on Amazon, Walmart, and eBay. We chose to invest millions of dollars on equipment and infrastructure in the US - without funding or help from our government.
Why M95?
We created a bi-fold cup mask with reliable ultra-high filtration, consistently comfortable material and durable ear-loops while implementing a high-quality nose bridge wire without the need of an exposed foam pad underneath. A product that was 5-layers rather than the traditional 4-layers which were common in KN95 and N95's. Our layering and materials were extremely selective - we tested thousands of samples from dozens of suppliers for material filtration, comfort, elasticity, skin irritation and bio-compatibility to ensure that we were not cutting any corners on materials or equipment used to make our product. We were targeting a product to serve our fellow Americans who are used to having the best of the best available to them with fast delivery.
We originally called this item an M95i to bring attention to the fact that our mask was just as good or better than the KN95's being imported from overseas. We are not advocating people in surgery settings or firefighters to use them on their daily high-risk missions to enter a burning building since there is a risk that an ear loop mask can get snagged and/or fall off of the ear during a critical part of their job. These professions are definitely NOT our target market. The general public needs a firefighter level filtration mask with convenient ear loops that is comfortable and fashionable to wear to work or do everyday activities.
We wanted people to ask the question: "What the heck is an M95?" to bring awareness to a class of products that is lacking in the new world that transpired after Covid19. We went on to register and list our masks with all the regulatory bodies which wanted our product in their domain. We even certified our newly created manufacturing and quality management processes under ISO9001:2015 by November of 2020 - just 8 months into our new project. We continue to improve and add additional certifications such as ISO13485:2015 for Medical Products to our growing list of credentials. Sure we would love to certify our products as a medical device because it DOES meet the medical requirements regarding filtration - but again, it was originally intended to give maximum protection while not sacrificing convenience and comfort to the General Public in this time of need.
Why the "i" in M95i?
When naming our new masks, we realized that N95's, KN95's and all masks in general were made only for adults. All certifications were also only for adult size masks. NIOSH certifications required fit tests, which we performed with Examinetics on our M95i masks, but only for adults. We decided to add the letter indicating the size of the product; something no other manufacturer had ever done. Masks had always been a “one size fits all” designation and NIOSH hadn’t thought that one day, amidst a pandemic, the N95 masks may be used by the general public - let alone small faced adults, kids, or at this stage of the omicron variant - children under the age of 6. We determined that a new labeling was needed to meet the needs of smaller adults and for children.
Our size labeling explained:
i = International Standard
c = Compact (intended for small adults and children ages 7+)
k = Kinder (intended for small people ages 6 and under)
From there, we went on to design the M95c for children ages 7+ and small adults. Our latest invention the M94k, intended for toddlers up to age 6, is a product that the market truly needs as more smaller children are getting infected and hospitalized. Neither NIOSH, the CDC, or the FDA has come to the rescue by creating certifications for masks of this size and caliber.
Disgraceful attacks on the Lutema brand:
With all our ingenuity and advancement on creating a new category of products - we have been attacked by the media and government alike. We were "accidentally" listed on the CDC Counterfeit Respirator list for over a year until we finally were removed from their list in January 2022. The New York Times has inaccurately added our brand into a negative article we did not deserve to be in by indicating we created a “non-categorized” product that was insinuated to be counterfeit. We did create a non-categorized product, but it was to meet the needs of the unique sizing of the general public, which hadn’t been done before. In order to protect our children and smaller adults during a pandemic, mask sizing needs to be rethought so that everyone is equally protected. One-size-fits-all masks designed for hazardous professions are not acceptable for the general public and we are working to meet the needs of the entire population and not individual professions. It simply is not reasonable to expect our fellow Americans to strap a white cup with yellow dual-elastics that were invented for occupational safety onto our kids faces to send them to school.
- Why are American retailers such as Amazon, Costco, Walmart and eBay filled with foreign made sub-par KN95's and fake N95's - yet the media directs its' disparagement towards brands that are a part of the American Mask Manufacturer Association (AMMA), which the Lutema brand is a part of?
- Why are there zero AMMA member products on the Walmart.com platform or in their stores?
- Why does Walmart refuse to add US manufactured respirators to their catalog? Are they so saturated with sub-par foreign made products with higher margins that they should be allowed to suppress high-quality masks made in America?
- Why are marketplaces taking government funding and excessive tax breaks allowed to take down US Manufactured products without recourse? Why are they not promoting the superior US manufactured products over low-grade foreign made products? (Not that all foreign made products are low-grade or sub-par)
- Why does Amazon.com consistently de-list AMMA products or remove AMMA listing pages - but they allow many foreign made products to manipulate its marketplace to rank as "Amazon's Choice" or "Amazon's Best Sellers"?
- The Lutema M95i and Lutema M95c were consistently on the Top 50 Best Sellers of Amazon until foreign importers attacked Lutema with fake reviews. They were even using Blackhat tactics and specific keywords to trigger Amazon's system to delist Lutema products.
Conclusion
So, we are here amidst a new surge during an omicron variant - manufacturing high quality unique products in the United States on fully automated machinery designed and redesign by MI Technologies team of engineers.
Amazon should be selling our products and making them Amazon's Choice, don't you think?
We are proudly one of the founding members of the American Mask Manufacturer's Association which helps promote critical PPE manufacturing on shore.
We would like our customers, critics, and soon to be customers to learn a little about the different masks that we have made available to the general public along our 21 month journey. We would like a chance to explain the differences between the various types of masks available and the intended use of each of them. We want to showcase our products alongside those "Standards" available to our fellow Americans:
NIOSH N95 Respirator
N95 – A mask manufactured in US, Mexico, or China and certified by US NIOSH/NPPTL with filtration levels exceeding 95% using a Sodium Chloride (NaCL Aerosol) test of particulates of 0.3microns while having a differential pressure (inhale/exhale) not exceeding 343/245 pascals (Pa) (34.3/24.5 mm H2O) while maintaining 85 liters per minute of constant airflow. (Per 42 CFR 84).
What is NIOSH?
National Institute for Occupational Safety and Health is a division of the Centers for Disease Control (CDC) which focus on occupational safety and health in the workplace. Inheritantly hospitals, firefighters, construction and manufacturing jobs handling hazardous materials.
What is NPPTL?
National Personal Protective Technology Laboratories is a division of the Centers for Disease Control (CDC) which focuses on laboratory testing methods and standards.
Requirements for NIOSH Certification:
- Dual Over-Head Elastics and Fit Testing
- Single Size fits All, Adults Only – There is no child standard
- Supplier and Raw Material Purchasing Controls in accordance with 42 C.F.R. Part 84 which also align with ISO9001:2015
- Quality Management System in accordance with 42 C.F.R. Part 84 which also align with ISO9001:2015
Intended Use:
- Hospitals specifically in a surgery setting or high-risk contagion environment
- Painting or Construction where Aerosols can enter human respiratory system
- Firefighting where dangerous fumes can enter human respiratory system
- Attics where dangerous mold can enter human respiratory system
- Specifically in areas where the risk of respirator falling off is extremely high as the use of both hands are always compromised
KN95 GB2626-2006 or GB2626-2019
Chinese Standard Respirator
KN95 – A mask manufactured in China and Certified to Chinese Standards GB2626-2006 or GB2626-2019 with filtration levels exceeding 95% using a Sodium Chloride (NaCL Aerosol) test of particulates of 0.3microns while having a differential pressure (inhale/exhale) not exceeding 350/250 pascals (Pa) (34.3/24.5 mm H2O) while maintaining 85 liters per minute of constant airflow. (Per GB2626-2006)
Requirements for GB2626-2016/2019 Certification:
- Made in China
- Earloops OR Dual Over-Head Elastics
- Single Size, Adults Only – There is no child standard
- No Fit Testing Required
- No Supplier or Raw Material Purchasing controls required
- Minimal Quality Management System requirements
- China Mandatory updated to GB2626-2019 with minor improvements
Intended Use:
- Hospitals specifically in a surgery setting or high-risk contagion environment
- Painting or Construction where Aerosols can enter human respiratory system
- Firefighting where dangerous fumes can enter human respiratory system
- Attics where dangerous mold can enter human respiratory system
(China should require overhead elastics like NIOSH does if they are using these in above areas... but they don't)
M95 US Made High-Filtration
General Public Protection Respirator
M95 – A mask manufactured by an MI Technologies, Inc. licensed manufacturer in the United States (Breathh, Inc.) with filtration levels exceeding 97% using a Sodium Chloride (NaCL Aerosol) test of particulates of 0.3 microns while having a differential pressure (inhale/exhale) not exceeding 343/245 pascals (Pa) (34.3/24.5 mm H2O) while maintaining 85 liters per minute of constant airflow (Per 42 CFR 84). Additionally tested for Particulate Filtration Efficiency (PFE) using latex particulates of 0.1 micron to ASTM F2100 standards exceeding 97% filtration. Additionally tested for Bacterial Filtration Efficiency (BFE) exceeding 97% Filtration.
Requirements for M95:
- Elastic Earloops intended for comfort
- Manufactured in the United States of America
- M95i International Standard Size - Ages 16+
- M95c Compact Size Mask - Small Adult or Children Ages 7+
- M94k – Extra small mask suitable for ages 6 and under
- Supplier and Raw Material Purchasing Controls in accordance with 42 C.F.R. Part 84 which also aligns with ISO9001:2015
- Quality Management System in accordance with 42 C.F.R. Part 84 which also align with ISO9001:2015
Intended Use:
- High congestion areas such as Airports, Airplanes, Public Mass Transit, Stadiums, and public gatherings amidst the Covid19 pandemic.
- Medium congestion areas such as grocery stores, restaurants, and small home gatherings amidst the covid19 pandemic.
- Not intended for Medical Use specifically in Surgical settings.
Source:
Our full M-Series naming convention explained:
M95-Series
- Ultra High Filtration
- 5 Layers
- Tested at 99%+ Filtration
High level filtration with 5 layers intended for maximum protection. 3 filtration layers including a layer of AAA+ electrocharged sponge pressed between two layers of AAA+ Meltblown filters.
M95i -
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
5 – 5 Layer Mask
i – International Standard Size
M95i Laboratory Testing Data (Click Here)
M95c -
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
5 – 5 Layer Mask
c – Compact/Small Adult/Child 7+ Size
M95c Laboratory Testing Data (Click Here)
M93-Series
- Ultra High Air Flow
- 3 Layers
- Tested at 97%+ Filtration
Lightweight, thin, yet effective. Allows better flow of air and voice can be heard much better. Some customers with asthma prefer the higher airflow even though it sacrifices some filtration. Single layer hydro-charged meltblown filter, that is a higher grade than current 3-ply surgical masks, and seals around the face like an M95 mask. May replace current surgical masks in the future.
M93i -
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
3 – 3 Layer Mask
i – International Standard Size
M93i Laboratory Testing Data (Click Here)
M93c –
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
3 – 3 Layer Mask
c – Compact/Small Adult/Child 7+ Size
M93c Laboratory Testing Data (Click Here)
M94-Series
- High Filtration for the Airflow
- 4 Layers
- Tested at 98%+ Filtration
High level filtration with 4 layers intended for high protection and better airflow – intended for smaller children with smaller lungs. 2 filtration layers including a layer of AAA+ electrocharged sponge and a single layer of a hydro-charged meltblown filter.
M94k –
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
4 – 4 Layer Mask
k – Kinder/Extra Small Size
M94k Laboratory Testing Data (Click Here)
M96-Series Valved Respirator
- Ultra High Filtration
- 6 Layers
- Tested at 99%+ Filtration
High level filtration with 6 layers intended for maximum inhalation protection and equipped with exhalation valve. 4 filtration layers including two layers of AAA+ electrocharged sponge and two layers of AAA+ Meltblown filters.
M96i -
M – MI Technologies, Inc. Folding-Style Mask
9 – 90%+ Filtration Guaranteed
6 – 6 Layer Mask with Valves
i – International Standard Size
What else is Lutema working on?
We continue to innovate in this sector and we have a few new products coming soon. Stay tuned as we intend to remain the leading manufacturer of high-filtration personal respirators in the United States.