510(k) K231618

3 Layer Surgical Mask (134252531) by Original Mattress Factory, Inc. — Product Code FXX

K231618 is an FDA 510(k) premarket notification submitted by Original Mattress Factory, Inc. for the device "3 Layer Surgical Mask (134252531)". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.