510(k) K102652

NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS by Gri Medical & Electronic Technology Co., Ltd. — Product Code FYA

K102652 is an FDA 510(k) premarket notification submitted by Gri Medical & Electronic Technology Co., Ltd. for the device "NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on February 3, 2011. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Gri Medical & Electronic Technology Co., Ltd. has at least 3 other 510(k) clearances on record.