Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

About This 510(k) Submission

K201732 is an FDA 510(k) clearance for the Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on February 16, 2021, 236 days after receiving the submission on June 25, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.