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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FYA FDA class 2

    Gown, Surgical

    General, Plastic Surgery

    View full classification →

    A surgical gown is a sterile garment worn by members of the surgical team to establish a bacterial barrier between the patient and non-sterile areas of the operative environment, reducing infection risk. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYA, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
    BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
    Cardinal Health™ Poly Reinforced Surgical Gown
    Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
    Copioumed AAMI 3 Surgical Gown
    Henan Yadu Level 4 Surgical Gowns (Reinforced)
    Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
    ViVi® Toga Premium
    Dream Medi Sterile Surgical Gown (SurgicalGownUL)
    Medline Level 4 Surgical Gown with Breathable Sleeves
    Stryker Steri-Shield 8 Surgical Hoods and Togas
    ProPel SG3™ Surgical Gown
    GCI Surgical Gown
    Disposable Surgical Gown
    Surgical Gown (40083)
    Skypro, Surgical Gown 6021
    Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
    Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
    Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
    Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets
    Surgical Gown
    High Protection Surgical Gown
    Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
    Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
    Surgical Gown
    SEJONG Surgical Gown Soft
    Surgical Gown
    Comfort Gown, Safewear Gown
    Surgical Gown
    Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
    Bodygard SFS Surgical Gown Level 4
    Disposable Surgical Gown Rk-3011C
    Disposable Surgical Gown (G4003)
    YADU Surgical Gowns
    Surgical Gown (Sterile); Surgical Gown (Non-sterile)
    Disposable Surgical Gown UM-148
    35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
    Sterile Level 3 Surgical Gown
    Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
    Medline Orbis LVL 3 Surgical Gown
    Plus Medical Cover Gown
    Medline Orbis Chemo Surgical Gown
    Plus Medical Chemotherapy Gown
    Disposable Surgical Gown
    Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
    Maxima Surgical Gown
    Surgical Gown
    Bodygard SFS Surgical Gown Level 3
    EndoArmor™ + Surgical Gown
    Surgical gowns

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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