510(k) K230395

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) by Durio Ppe Sdn Bhd — Product Code FXX

K230395 is an FDA 510(k) premarket notification submitted by Durio Ppe Sdn Bhd for the device "Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.