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

About This 510(k) Submission

K201421 is an FDA 510(k) clearance for the 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, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on February 5, 2021, 252 days after receiving the submission on May 29, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.