510(k) K060181

COMPE1 1 -PLY SURGICAL GOWNS by Standard Textile Co., Inc. — Product Code FYA

K060181 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "COMPE1 1 -PLY SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on March 7, 2006. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.