510(k) K221209

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops by Padm Medical, Inc. — Product Code FXX

K221209 is an FDA 510(k) premarket notification submitted by Padm Medical, Inc. for the device "PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops". The FDA issued a decision of Substantially Equivalent on Mar 8, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.