Shopping for a high-performing mask is a daunting task and claims of FDA approval would certainly make life easier but, spoiler alert, there’s no such thing as “FDA-approved” masks! There are however a number of FDA hoops that manufacturers can jump through to indicate some degree of quality and performance.
Surgical face masks are regulated as Class II Medical devices with FDA device code FXX. Surgical face masks require FDA 510k clearance to market in the USA. After getting 510k clearance, the manufacturing establishment must register with FDA and list the surgical mask with FDA using the cleared 510k number.
Face masks: A mask, with or without a face shield, covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks should be used by the general public and health care personnel as source control in accordance with CDC.
Surgical masks: A mask intended for medical purposes that cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements. Surgical masks are also tested for particulate and bacterial filtration efficiencies and biocompatibility and are considered personal protective equipment (PPE).
The FDA regulates face masks as medical devices when they are intended for medical purposes. Face masks marketed to the public for non-medical use, such as industrial and gardening activities, are not regulated by FDA.
FDA Classification for Medical Masks
| Maximum Marketing Designation* | Medical Device Class | FDA Submission Type | Mask Information | ||
| Recommended Standard | Description | Product Code | |||
| FDA-Cleared | II | 510(k) | ASTM F2100, ASTM F2101, ASTM F1862 | Mask, Surgical | FXX |
| Surgical mask with antimicrobial/antiviral agent | OUK | ||||
| Pediatric/Child Facemask | OXZ | ||||
| FDA-Authorized | Not Classified | EUA | See EUA | Mask, Surgical, Eua Authorized | QMF |
| FDA-Listed | Not Classified | Enforcement Discretion** | ASTM F3502 | Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency | QKR |
FDA-Cleared Masks
FDA-Authorized Masks
FDA-Listed Masks
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