510(k) K230707

Skypro, Surgical Gown 6021 by Skypro Medical Supplies Company — Product Code FYA

K230707 is an FDA 510(k) premarket notification submitted by Skypro Medical Supplies Company for the device "Skypro, Surgical Gown 6021". The FDA issued a decision of Substantially Equivalent on October 12, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Skypro Medical Supplies Company has at least 2 other 510(k) clearances on record.