510(k) K221534

Surgical Face Masks (Ear Loops And Tie-On) by San-M Package Co., Ltd. — Product Code FXX

K221534 is an FDA 510(k) premarket notification submitted by San-M Package Co., Ltd. for the device "Surgical Face Masks (Ear Loops And Tie-On)". The FDA issued a decision of Substantially Equivalent on September 16, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. San-M Package Co., Ltd. has at least 2 other 510(k) clearances on record.