510(k) K221038

Disposable Medical Masks by Hantech Medical Device Co., Ltd. — Product Code FXX

K221038 is an FDA 510(k) premarket notification submitted by Hantech Medical Device Co., Ltd. for the device "Disposable Medical Masks". The FDA issued a decision of Substantially Equivalent on September 1, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Hantech Medical Device Co., Ltd. has at least 4 other 510(k) clearances on record.