510(k) K261949

NYES Tuff Cuff L3 Disposable Gowns by New York Embroidery Studio — Product Code FYA

K261949 is an FDA 510(k) premarket notification submitted by New York Embroidery Studio for the device "NYES Tuff Cuff L3 Disposable Gowns". The FDA issued a decision of Substantially Equivalent on July 10, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.