510(k) K232112

R&G Surgical Mask by R&G Seguridad E Higiene Industrial S.A.C. — Product Code FXX

K232112 is an FDA 510(k) premarket notification submitted by R&G Seguridad E Higiene Industrial S.A.C. for the device "R&G Surgical Mask". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.