Why aren’t these masks for medical use—what do they lack?

It may be helpful to understand the difference between surgical and non-surgical respirators: • Surgical N95 respirators are both 1) approved by NIOSH as an N95 respirator and 2) also cleared by the Food and Drug Administration (FDA) as a surgical mask. These are classified as medical devices by the FDA and are designed to be worn by healthcare professionals during medical procedures. • Non-surgical N95 respirators are approved by NIOSH only. They are not approved by the FDA and are not classified as medical devices. Both surgical N95 respirators and the Kimtech non-surgical N95 respirator meet minimum filtration requirements. Surgical N95 respirators have additional required features such as fluid protection resistance for splashes and sprays. While these added features are important in healthcare settings, they are not necessary in the industrial and scientific segments served by Kimberly-Clark. Our NIOSH-approved non-surgical Kimtech N95 pouch-style respirator has been specifically designed for non-medical use. It has not been cleared by the FDA as a medical device. It is therefore not for medical use.

I see some warning this is not genuine. how to determine? its s&s amazon.

This product is sold directly from Kimberly-Clark to Amazon. As you can see the “ships from” and “sold by” are both Amazon. Through the years, Kimberly-Clark has developed and sold numerous NIOSH-Approved products. As you will see in the comments, some individuals believe that this product is ingenuine or a knock-off of a pre-existing Kimberly-Clark product. This is not accurate. This is new product that was created in 2020 and has been approved by NIOSH (TC# 84A-9042). Every respirator will come in a bag of 50 with a Directions for Application insert. Also, every N95 has printing on the bottom of the respirator. If you are still in doubt, please contact Kimberly-Clark Professional via the phone number, email address or website that is listed on the front of the bag.

how many layers do these masks have?

I took this mask apart and it has 4 layers to it. I also called the company to ask why it is listed as n95 but is not intended for medical use. I was told it meets requirements for n95 but has not been tested for medical use but rather to filter out particulates, contaminates, etc. Also, It has not been tested for Covid 19. However, with that being said, I find it to be a great mask. It has 4 layers, fits well for a better seal than other masks I have bought. As I mentioned, when taken apart I found 4 layers.

are they individually packaged?

BEWARE... The masks themselves are not individually packaged; rather, they come as 50 masks lumped together in a plastic bag. The last three orders of 50 masks per bag I received contained 5 out 6 bags that had been opened and were no longer factory sealed (unsanitary)! Only one of the 6 bags was taped closed. Each order was for 2 bags. This is unfortunate because I really like the design, comfort and fit of these masks.

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🛡️ Stay sharp, breathe smarter, lead safer.

CUSTOM COMFORT FIT - Pouch design with a large breathing chamber plus bendable nosepiece and soft, strong headbands for a secure, personalized fit.
BREATHE EASY WORK HARD - Up to 75% more breathable than the NIOSH minimum, designed for all-day comfort without compromise.
BULK READY FOR PROFESSIONALS - 50 respirators per bag—perfect for managers and teams who demand reliable protection without constant restocking.
TRUSTED AMERICAN CRAFTSMANSHIP - Proudly made in the USA by Kimberly-Clark, ensuring quality and compliance with TAA and FDA EUA standards.
ELITE PROTECTION EVERYDAY CONFIDENCE - NIOSH-approved N95 filtration blocks 95% of 0.3 micron particles, keeping you safe in any environment.

The KIMTECH Kimberly-Clark Professional N95 Pouch Respirator offers NIOSH-approved 95% filtration efficiency with superior breathability and a customizable fit. Made in the USA and TAA compliant, this pack of 50 respirators combines trusted protection with all-day comfort, ideal for professionals seeking reliable respiratory safety outside healthcare settings.

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