510(k) K221134

Procedure Mask with Ear Loops and Surgical Mask with Ties by Safesource Direct, LLC — Product Code FXX

K221134 is an FDA 510(k) premarket notification submitted by Safesource Direct, LLC for the device "Procedure Mask with Ear Loops and Surgical Mask with Ties". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Safesource Direct, LLC has at least 2 other 510(k) clearances on record.