How has the FDA’s opinion about n95 masks changed over time?

N95 respirator

The N95 respirator is a respiratory protective device, and it is the most crucial Personal Protective Equipment (PPE) which protects the wearer from inhaling airborne particles that could be harmful to a person’s health. The N95 respirator is 95 percent efficient at filtering out harmful airborne particles. These airborne particles include fog, infectious agents, dust, dirt, and smog, etc. The N95 respirators keep the wearer safer than other masks. 3M has manufactured the most amounts of N95 respirators.

The N95 respirator filters out or blocks natural aerosols from getting into an individual’s body through the nose. Natural aerosols could harm an individual and cause harmful diseases like lung cancer, cardiovascular diseases, and heart disease, etc. Natural aerosols include dust, smog, and fog, etc. The distinction between N95 respirators and other masks is that the N95 respirator can filter out particles that are smaller than 0.3um. Since the pandemic began, wearing the N95 respirator has become crucial to protect yourself from getting infected by this fatal disease.

FDA

FDA is responsible for ensuring the safety and protection of the people of the United States by verifying the safety and effectiveness of human drugs, cosmetic products, medical devices, biological products, vaccines, medicines, and veterinary drugs. Furthermore, the FDA also keeps a close check on America’s food supply and products that emit radiation. The FDA plays a major role in preventing the people of the United States of America from harmful infectious and viral diseases.

What the FDA does is it also keeps a close check at the products which are consumed by the public as such products could cause carcinogens that may be harmful to the wearer. The FDA supports those corporations as well that works for the safety of the public of the United States. If the FDA approves a product, it means that the product will safeguard the public, and the public can benefit from it. The full form of the FDA is the Food and Drug Administration.

The sister of the FDA is the CDC (Centers for Disease Control and Prevention). At the start of the pandemic, the CDC recommended the public, doctors, nurses, and other healthcare professionals to wear the N95 respirators to deal with this lethal disease. The CDC said this statement when the N95 respirators had not been short.

When the N95 respirators got short, the CDC recommended the public to wear surgical masks and cloth masks; this is because the N95 respirators got short because thousands of people had already bought N95 respirators when the pandemic began. Therefore, the CDC recommended the public to wear surgical and cloth masks.

When the N95 respirators first came to the market, the FDA said that the N95 respirators should not be decontaminated since using harsh chemicals could adversely affect the N95 respirator. But when the pandemic hit the United States in the early months of 2020, the demand for N95 respirators rose to an alarming rate!

Thousands had already bought the N95 respirator, but there were millions who would not have access to N95 respirators because of the national shortage. Therefore, some decontamination methods of N95 respirators were cleared by the FDA to deal with the national shortage. People, who had run out of N95 respirators, decontaminated their N95 respirators through dry heat and reused it.

The FDA always recommends that an individual must always use the new cleared N95 respirator than the decontaminated one because that decreases the chances of the user contracting the disease. Apart from that, the FDA’s opinion of N95 respirators has not changed at all. When the N95 respirators were made, the FDA had said that the N95 respirator can easily filter out harmful airborne particles. 

The FDA had recommended the N95 respirators for the public, doctors, nurses, physicians, and other healthcare professionals; this is because N95 respirators are effective at keeping an individual safe from contagious diseases like the influenza virus and COVID-19. Contagious diseases are those diseases that spread when an infected individual comes in contact with another individual. 

When a person inhales the harmful airborne particles of the infected individual, that person also gets infected. The influenza virus spreads in a similar way as well. When the influenza virus broke out in 2009 in the United States, the FDA cleared the N95 respirators for the people of the U.S. to curb the lethal spread of the influenza virus.

The same thing happened when COVID-19 broke out in Wuhan and came to America. The FDA approved N95 respirators for the people’s use to combat COVID-19 since the N95 respirator is the most crucial Personal Protective Equipment (PPE). The FDA approves those masks that pass certain tests. Those tests check the quality, durability, breathability, and comfortability of the mask. The masks that have such characteristics are approved by the FDA for the use of the public. Since the N95 respirator can protect people from harmful and contagious diseases, the FDA approved it. 

Conclusion

The CDC recommends that the N95 respirators should be used by healthcare professionals like doctors, nurses, and physicians, etc. In addition to that, the CDC says that the public must use surgical masks and cloth masks to deal with the shortage. The FDA’s opinion about N95 respirators has not changed at all, and the FDA has always considered the N95 respirator as a crucial Personal Protective Equipment (PPE). 

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