510(k) K230577

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi — Product Code FYA

K230577 is an FDA 510(k) premarket notification submitted by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi for the device "Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)". The FDA issued a decision of Substantially Equivalent on Aug 16, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.