510(k) K140539

AERO BLUE PERFORMANCE SURGICAL GOWN by Kimberly-Clark Corporation — Product Code FYA

K140539 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corporation for the device "AERO BLUE PERFORMANCE SURGICAL GOWN". The FDA issued a decision of Substantially Equivalent on June 9, 2014. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark Corporation has at least 10 other 510(k) clearances on record.