510(k) K213001

Procedure Mask, Surgical Mask by A Plus International, Inc. — Product Code FXX

K213001 is an FDA 510(k) premarket notification submitted by A Plus International, Inc. for the device "Procedure Mask, Surgical Mask". The FDA issued a decision of Substantially Equivalent on May 11, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. A Plus International, Inc. has at least 10 other 510(k) clearances on record.