510(k) K252575

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) by New York Embroidery Studio (NYES) — Product Code FYA

K252575 is an FDA 510(k) premarket notification submitted by New York Embroidery Studio (NYES) for the device "Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.