Since March of 2020, the CDC changed policies by issuing an FDA-EUA regarding N95 mask which changed the use protocol.
Most N95 masks are used in the industrial fields not medical and medical has a higher verification standard so were are going to try and break down for you a simple explanation of the standard masks.
- N95 – NIOSH Approved – Surgical – FDA Cleared – These are the masks that medical professions were required to use before March of 2020 – Because of the expenses involved and the time to approve these masks are used by medical professionals. MOST expensive
- N95 –NIOSH Approved – Blanket FDA-EUA – NIOSH not only goes through rigorous testing of the respirators, requires manufacture to report issues with them, but also regularly buys and tests these masks. These masks were used in industrial settings (such as painting and chemicals, but after the blank FDA-EUA can be used in medical situations). Expensive
- NON – NIOISH approved – FDA-EUA masks individual companies were able to test their non-NIOSH approved masks. If the FDA/CDC found them acceptable they would give that specific company and FDA-EUA for the mask and model number. Cheaper
- KN95 – FDA-EUA – In Oct 2020 the FDA issued a blank EUA for certain KN95 models from China. This was in response to the medical community affirmations that the KN95 was not adopted by the medical community and could be adopted for civilian use. The FDA decided to specifically issue to the blanket FDA for approved models only. For more information click here. Cheaper
- NON-NIOSH approved – NON-FDA – Respirators that are approved by foreign governments. These are respirators or masks that can be marketed as surgical masks but not N95 masks. The governments that authorized them are non-recognized by the FDA in a blanket EUA. Cheaper