What it means when a mask is "FDA cleared"

What are N95 masks?

N95 is the equipment used to cover the face to protect against any kind of airborne particles. This mask is approved by many health care organizations all around the world to use for the safety of the public. It consists of multi-layer, non-woven synthetic fibers that make it capable of filtering various kinds of small and large-sized particles present in the air and give complete protection against them. It gives 95% protection against different bacteria, fungus spores, viruses, and other dust particles present in the atmosphere.

NIOSH, FDA, CDC cleared:

Many Public health care authorities check many surgical products and other equipment that are used in the medical centers and hospitals to ensure the quality and protection rate of those products against harmful factors so that they can't be harmful to people when they use them to protect themselves in different countries. So these public health care authorities have approved the N95 mask to use in the public because of its high-quality protection against the harmful airborne particles of different types.

All of these departments are involved in the regulatory process of the N95 masks.

FDA guidelines:

FDA is our food and drug administration that works to analyze all the medical equipment and other drugs made for the medical process to assure that they are safe for public use. Unlike other public health care organizations, the FDA has its method to approve any kind of drug or equipment that assures the quality and safety of the products used by people in different areas all around the world.

It's not depending on any other organization to approve any product it works according to its criteria that it has designed for all kinds of medical types of equipment or drugs and that makes it authorities on their work.

FDA approval process:

It's not a simple task to approve any product before it goes to the market and could be used by medical institutions. This approval process depends upon the number of different stages and steps that are followed by a huge hub of medical specialists to test the qualities and drawbacks of a specific product to ensure its nature and how it can affect the human when it'll be used by them. A huge number of people work in this organization and all of them are medical specialists and professionals in the medical field.

They oversee the products manufactured by different companies and ensure the fact that is this specific product safe for public use or not. And they gave instructions to all medical institutions about the product that, should they use this product or they are not suitable to use for any medical purpose. This process is not that simple as it looks. It requires months to examine all the manufactured products and then approve them in public health care centers. It's a lengthy process that needs a specific time and duration to be accomplished by the FDA.

FDA has approved N95 masks for use in public and medical centers like hospitals and clinics because of its high-quality stuff that it's made up of. Approval of N95 masks also needed months to be accomplished and it consists of different stages that are followed by specialists. Here is some point that represents the approval process of the FDA for N95 masks:

  • Analysis of the manufactured products of N95 that are just going to be used in the market and by the people, to examine these masks.
  • Examining its quality, what kind of material is used in it, and how can make any impact in different ways to see the safety level of N95 masks.
  • Use the limit of these products for how long these masks can be used by a person to use them daily because every product has their own shelf life and it's necessary to check this factor, otherwise it could be dangerous for the health of people.
  • Examining its sensitivity by how much sense it has to human skin. It means this step is followed to check out that this mask can be allergic to human skin if it makes contact with their skin because e mostly such kinds of products cause these e side effects in severe conditions.
  • Clinical research: that is done to see what kind of chemicals are used in its manufacturing and are they dangerous for human health if people inhale them during breathing.

Analysis of the mentioned properties of the product that is given by manufacturers. This step is really important because without this no one can know if the manufacturing companies are making right N95 masks for public use or not.

At the end of these all analysis stages, the FDA gives it reviews about this product and does final testing as if the process is complete or still there are some measures to be adopted.

And finally, they declare N95 masks to be used by people and medical centers.


The N95 mask is perfect to be used by people in all aspects to protect themselves, and these N95 masks are approved by FDA, even though it has strict strategies to check the quality of a product. But N95 masks have passed all those quality tests that are needed to be FDA, NIOSH, CDC authorities. So it makes it suitable for public use in different countries.

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