510(k) K203237

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 by Dukal Corporation — Product Code FYA

K203237 is an FDA 510(k) premarket notification submitted by Dukal Corporation for the device "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". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Dukal Corporation has at least 6 other 510(k) clearances on record.