COVID-19: A Guide for Pandemic. KN95 and N95 Masks

Around the world, guidelines and regulations have been created for filtering respirator helmets. These guidelines and standards specify the requirements that must be met by a country to meet certain standards. Health authorities may allow foreign standards to be used for facepiece respirators in emergency situations such as pandemics and epidemics. This article will identify and describe the most commonly used respirator standards around the globe. This article will provide an overview of FDA's regulatory framework in the United States for 2019 novel coronavirus and associated COVID-19 pandemic.

N95 Respirator Masks

This is the most widely used and popular respirator in America. It can filter up to 95% of particles and seals the mouth with an airtight seal. These respirator masks are not subject to FDA regulations. NIOSH and CDC regulate them. The FDA can regulate a manufacturer's N95 mask if it wants to market it for medical purposes. In response to the COVID-19 pandemic, the FDA issued guidance March 2, 2020. The FDA guidance stated that NIOSH-approved respirators can be used by healthcare workers in a healthcare setting during an epidemic of coronavirus.

FFP2 Respirator Masks

FFP2 respirator masks have been certified by the European Union to meet the CE regulation EN149.2001+A1:2009 standards for filtering particles to 94%. FDA announced that FFP2 masks for filtering particles up to 94% have been approved by the European Union.

KN95 Respirator Masks 

KN95 masks are subject to regulation GB2626-2006 by the Chinese government. They filter 95% of particles. In April 2020, the FDA issued guidance allowing for the use of KN95 masks made in USA to NIOSH purposes in certain emergency situations.

Additional guidance was issued by FDA on May 7, 2020, to revise April's guidance.

N95 Masks vs KN95 Masks vs FFP2

N95 and KN95 masks can filter up to 95% of particles and create an airtight sealing around the skin. FDA approved FFP2 and KN95 emergency masks for NIOSH-approved N95.

On May 7, 2020, the FDA issued additional guidance to replace April's April guidance.

There are also differences in N95 and KN95 masks. KN95 masks are designed to be worn with the ear loop, while N95 masks have two head-strap attachments. The one that goes around your back below your ears and the other above your crown goes around your head. The mask that is most comfortable for you will depend on your personal preference. It all depends on how safe and protected the activity is.

The KN95 takes less time to put on and take off, while the N95 is more comfortable and fits better. N95 masks offer more protection, but are slightly less comfortable than the KN95. NIOSH-approved N95 masks cost slightly more than the KN95/FFP2 models.

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