510(k) K093115

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 by Kimberly-Clark Corp. — Product Code FYA

K093115 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100". The FDA issued a decision of Substantially Equivalent on March 19, 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.