510(k) K211861

TAIJI Professional Series Level 3 Surgical Face Mask by Taiji Medical Supplies, Inc. — Product Code FXX

K211861 is an FDA 510(k) premarket notification submitted by Taiji Medical Supplies, Inc. for the device "TAIJI Professional Series Level 3 Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on Jul 28, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.