![]() Surgical masks are Class II medical devices. Surgical masks: A mask intended for medical purposes that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials.Barrier face coverings: As described in ASTM F3502-21, a barrier face covering is a product worn on the face, specifically covering at least the wearer's nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter.Face masks should be used by the general public and health care personnel as source control in accordance with CDC recommendations on Interim Infection Prevention and Control, or in other situations as appropriate based on personal circumstances. Face masks: 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.The Basics on Face Masks, Barrier Face Coverings, Surgical Masks, and RespiratorsĪ: Face masks, barrier face coverings, surgical masks, and respirators all cover a wearer's nose and mouth, but they differ in several aspects. Notifying the FDA of shortages of or problems with face masks, surgical masks, or respirators.Purchasing face masks, barrier face coverings, surgical masks, and respirators during the COVID-19 pandemic.Manufacturing and importing face masks, barrier face coverings, surgical masks, and respirators during the COVID-19 pandemic. ![]() Emergency Use Authorizations for face masks, surgical masks, and respirators.Using face masks, barrier face coverings, surgical masks, and respirators.The basics on face masks, barrier face coverings, surgical masks, and respirators.The FDA regularly updates its communications about face masks, surgical masks, and respirators, including the answers to frequently asked questions on this page. To help expand the availability of face masks, barrier face coverings, surgical masks, and respirators, the FDA is providing certain regulatory flexibility for the duration of the COVID-19 public health emergency, as described in the Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency and Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, and has issued emergency use authorizations (EUAs) for face masks, surgical masks, and respirators that meet certain criteria. The information provided may be useful to manufacturers and importers of face masks, barrier face coverings, surgical masks, and respirators, as well as health care facilities and health care personnel. Non health care use of face masks and respirators intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use.Powered respirators, such as powered air purifying respirators (PAPRs).This page provides information on face masks, barrier face coverings, surgical masks, and respirators (filtering facepiece respirators, such as N95 respirators) intended for a medical purpose to assist in preventing the spread of infectious materials during the COVID-19 pandemic. Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023.Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances. The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. Taking other actions with respect to these devices. ![]()
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