510(k) K201421

Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons by Dukal Corporation — Product Code FXX

K201421 is an FDA 510(k) premarket notification submitted by Dukal Corporation for the device "Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons". The FDA issued a decision of Substantially Equivalent on February 5, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Dukal Corporation has at least 6 other 510(k) clearances on record.