510(k) K253243

Cardinal Health™ Poly Reinforced Surgical Gown by Cardinal Health 200, LLC — Product Code FYA

K253243 is an FDA 510(k) premarket notification submitted by Cardinal Health 200, LLC for the device "Cardinal Health™ Poly Reinforced Surgical Gown". The FDA issued a decision of Substantially Equivalent on April 28, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Cardinal Health 200, LLC has at least 3 other 510(k) clearances on record.