510(k) K103406

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS by Kimberly-Clark Corp. — Product Code FYA

K103406 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on December 23, 2010. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.