There is an outbreak of respiratory disease caused by a novel coronavirus called “Coronavirus Disease 2019” (COVID-19) and it raised shortages of face masks, surgical masks, and respirators due to extremely high demand.
Currently, there are many products marketed in the United States as “face masks” that offer a range of protection against COVID-19, but it might not guarantee the proper protection always. According to the guidance of the FDA, face masks and respirators are regulated by the FDA when they meet the definition of medical devices.
Three Types of Face Masks
To put it simply, there are three types of face masks and respirators. (please see the table below for details.)
1. Face Mask (non-surgical mask)
Face mask is a mask with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Most likely, DIY/Cloth masks are in this category and they are not applicable to medical devices or protective equipment.
2. Surgical Mask
A mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests. Surgical masks are also tested for biocompatibility and are considered personal protective equipment (PPE). While a surgical mask may be effective in blocking splashes and large-particle droplets, they do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face. Surgical masks are not respiratory protective devices such as respirators.
3. Respirators, known as filtering facepiece respirators (FFRs)
A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth). N95 respiratory masks offer protection from particulate materials at an N95 filtration efficiency level (filter at least 95 percent of airborne particles). Including N95, they are PPE that tightly fit the face and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic airborne particles in a health care setting. They provide a higher level of protection against viruses and bacteria when properly fit-tested.
And here is the different types of masks with product codes presented by the FDA.
Difference Between General Masks and Surgical Masks
Non-medical masks or fashion face masks including homemade masks are not regulated by the FDA, they are labeled only for general purposes such as industrial use. Now they are easily seen and even many people are trying to make DIY face masks at their homes as the pandemic continues. However, despite its widespread availability, one must use these masks at their own risk since these masks do not promise any protection from viruses or hazardous fluids.
On the contrary, surgical/medical masks are regulated by the FDA as they are marketed for medical purposes. Medical purposes include uses related to COVID-19, such as face masks to help stop the spread of disease, surgical masks, and surgical masks with antimicrobial/antiviral agents.
Difference Between Surgical Masks and N95 Respirator
What You Should Prepare for Manufacturing, Importing, or Distributing Surgical Face Masks or N95 Respiratory Masks
In order to import or distribute surgical masks, importers or distributors must comply with the FDA with adequate testing reports.
And here are the lab-testing requirements below:
Bacterial filter performance
Particle filter performance
Differential pressure as an indicator of breathability
Microbiological purity
Skin compatibility using cytotoxicity test
For masks with splash resistance: penetration test using synthetic blood
N95 respiratory masks also require similar lab-testing requirements above and also require a NIOSH approval (The National Institute for Occupational Safety and Health), assuring respirators used in the workplace meet the standards of 42 CFR Part 84.
As the current crisis continues, FDA constantly changes and updates their policies and procedures for face mask regulation. So it is important to keep track of current changes and if you have any questions or concerns about surgical face masks or N95 respiratory masks, including lab tests, please feel free to get in touch with us at, ask@provisionfda.com
Source: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-including-surgical-masks-and-respirators-covid-19