Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

About This 510(k) Submission

K203237 is an FDA 510(k) clearance for the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on March 18, 2022, 500 days after receiving the submission on November 3, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.