Upgrade your face masks: Where to buy N95, KN95 respirators approved by CDC, FDA. The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Other powered air purifying respirators (PAPRs) approved by NIOSH. Do they offer the protection needed? If you need help with the pre-EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov. Health care facilities may review the list of device types to determine which devices may be included in the shortage or discontinuation lists. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. The site is secure. N95 respirators are not designed for children or people with facial hair. Product has been authorized by FDA under an EUA for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the current pandemic. N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless: The FDA has a Memorandum of Understanding (MOU) with CDC NIOSH which outlines the framework for coordination and collaboration between the FDA and NIOSH for regulation of this subset of N95 respirators. Refer to "During the COVID-19 pandemic, are there special considerations for surgical and other procedural care settings, including performance of aerosol-generating procedures (AGPs)?" Why buy our mask: This is an FDA approved mask that is extremely high quality. To safely discard your mask, place it in a plastic bag and put it in the trash. The CDC provides information on Using PPE and Considerations for Wearing Masks. Personal Protective Equipment for Infection Control, Recalls, Market Withdrawals and Safety Alerts, Personal Protective Equipment for Infection Control, N95 Respirators, Surgical Masks, and Face Masks, Questions About Personal Protective Equipment (PPE), FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic, Personal Protective Equipment (PPE) and Other Government Agencies, Face Masks, Including Surgical Masks, and Respirators for COVID-19, Considerations for Selecting Respirators for Your Health Care Facility, Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers, Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication, Manufacturing and Distributing Respirators for Health Care Use in the United States, N95 Respirators Not for Use by the General Public, CDC Recommends Cloth Face Coverings for Use by the General Public, Comparing Surgical Masks and Surgical N95 Respirators, N95 Respirators in Industrial and Health Care Settings. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Note that N95 respirators with exhalation valves should not be used when sterile conditions are needed. Public Goods KN95 Filter Face Masks. The .gov means it’s official.Federal government websites often end in .gov or .mil. If you are a health care facility, check with your supplier, distributor, or your local health department. This CDC infographic (PDF - 227KB) explains the differences between surgical masks and N95 respirators. WellBefore carries a variety of KN95 face masks in stock, including FDA-approved & FDA-registered KN95 masks for sale. Face masks, surgical masks, and respirators. A: The FDA regulates face masks, including cloth face coverings, and surgical masks as medical devices when they are marketed for medical purposes. Non-valved, authorized FFRs (authorized respirators without exhalation valves) that are decontaminated using an authorized or cleared decontamination system. The FDA encourages health care facilities which anticipate a potential shortage or are experiencing an actual shortage to notify the FDA.