FYA — Gown, Surgical Class II

FDA Device Classification

Classification Details

Product Code
FYA
Device Class
Class II
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251860copioumed internationalCopioumed AAMI 3 Surgical GownFebruary 26, 2026
K252301yadu medical (henan) coHenan Yadu Level 4 Surgical Gowns (Reinforced)February 4, 2026
K250564yadu medical (henan) coSurgical Gown (Level 3: S, M, L, XL, XXL, XXXL)December 3, 2025
K243522thi total healthcare innovationViVi® Toga PremiumMay 30, 2025
K242937dae myung chemical co., ltd. (vietnam)Dream Medi Sterile Surgical Gown (SurgicalGownUL)May 5, 2025
K242844medline industriesMedline Level 4 Surgical Gown with Breathable SleevesFebruary 26, 2025
K241272stryker instrumentsStryker Steri-Shield 8 Surgical Hoods and TogasOctober 16, 2024
K241214standard textile coProPel SG3™ Surgical GownSeptember 10, 2024
K233571george coureyGCI Surgical GownAugust 2, 2024
K233068nanning tecbod biological technology coDisposable Surgical GownMarch 29, 2024
K233183ammex-weida (hubei) health and safety products coSurgical Gown (40083)February 1, 2024
K230707skypro medical suppliesSkypro, Surgical Gown 6021October 12, 2023
K230610dongguan shin yi healthcare products factoryDisposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (LevAugust 23, 2023
K231510xiantao zhibo non-woven products coSurgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)August 22, 2023
K230577medcare saglik urunleri sanayi ve ticaret anonim sirketiSterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)August 16, 2023
K230838cardinal health200Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ InstrumenJuly 27, 2023
K222999hubei woozon healthcare coSurgical GownJune 16, 2023
K2224563a medical products coHigh Protection Surgical GownMarch 12, 2023
K223401xiamen probtain medical techology coDisposable Surgical Gowns (S,M,L,XL,XXL,XXXL)March 7, 2023
K221559stringkingDisposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3February 23, 2023