510(k) K230093

Disposable 4 Layers Surgical Face Mask by Social Medical Supply, LLC — Product Code FXX

K230093 is an FDA 510(k) premarket notification submitted by Social Medical Supply, LLC for the device "Disposable 4 Layers Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on Mar 2, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.