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Enter the terms you wish to search for. The FDA will continue to monitor the supply chain and update the list as the COVID-19 public health emergency evolves. The FDA also updated its Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about what device product codes the FDA has determined are appropriate to remove from the device shortage list. N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from particles or from liquid contaminating the face. It is important to recognize that the optimal way to prevent transmission of microorganisms, such as viruses, is to use a combination of interventions from across the hierarchy of controls, not just PPE alone. Face Masks A face mask is a product that covers the wearer’s nose and mouth. Barrier face coverings may be made from a variety of materials that are not flammable.
By definition, a barrier face covering should meet the particulate filtration efficiency, airflow resistance, and leakage assessment recommendations as described in ASTM F3502-21. Surgical Masks A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield.
Surgical masks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others. While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, it does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also 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 intended to be used more than once. If your surgical mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove it, discard it safely, and replace it with a new one. To safely discard your surgical mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.