510(k) K203101

Secure Wear USA Surgical Face Mask by Secured Ortho Manufacturing Of America, LLC — Product Code FXX

K203101 is an FDA 510(k) premarket notification submitted by Secured Ortho Manufacturing Of America, LLC for the device "Secure Wear USA Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on Mar 31, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.