510(k) K210147

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield by Unicoglobal, Inc. — Product Code FXX

K210147 is an FDA 510(k) premarket notification submitted by Unicoglobal, Inc. for the device "Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield". The FDA issued a decision of Substantially Equivalent on Dec 22, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Unicoglobal, Inc. has 1 other 510(k) clearance on record.