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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: LYU FDA class 1

    Accessory, Surgical Apparel

    General, Plastic Surgery

    View full classification →

    The Surgical Apparel Accessory (product code LYU) is a supplementary item worn by surgical team members, such as additional covers, wraps, or protective components used in conjunction with standard surgical gowns and attire. Regulated under 21 CFR 878.4040 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty with review by the General Hospital (HO) panel. It is not an implant, is not life-sustaining, and is not GMP-exempt.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    STRYKER T4 HYTREL (R) TOGAS
    NURSES BOUFFANT CAP
    FAR-EAST BOUFFANT CAPS
    DISPOSABLE APRON
    DEPUY DISPOSABLE FILTER/HOOD
    AMMI MAGNI-GUARD
    SLOAN STA-DRI PANT PROTECTOR
    ULTRAFIT LINERS
    I-SPOUSE
    SPLASH ASSIST
    ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
    SLOAN STA-DRI BOOTLEG LEGGING
    SLOAN STA-DRI SURGICAL JUMPSUIT
    INTEC FULL FACE SHIELD
    INCASE EXTENSIBLE BAG--NON-STERILE
    CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
    OP-D-OP II
    MAKAR FULL AND HALF FACE SHIELD
    MONOGARD FACE SHIELD
    BOUFFANT CAP
    SHOE COVER
    BODY BOOT
    SPLASH MASK
    FACE-IT SHIELD
    DERMAL GLOVES
    NYLON LINER GLOVES
    KACEY DISPOSABLE GLOVE LINER
    MOORE SECURE CAP
    SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
    TECNOL SPLASHGUARD
    PROCEL(TM) DERMALINER GLOVE
    AGAFAR FACE SHIELD
    ISOLAIR 2 FULL FACE SPLASH GUARD
    ACTION MEDTEK FACE SHIELD
    CATALOG NUMBER 111 (FACESHIELD)
    ULTRATUFF CUT RESISTANT GLOVE LINER
    WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
    MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
    GUARDALL SHIELD
    FINGGUARD
    REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
    MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV
    MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO
    NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
    OP-D-OP VISOR SHIELDS
    PARADERM(TM) SURGEON'S GLOVE ACCESSORY
    SURGICAL COTTON GLOVES
    CUT RESISTANT GLOVE LINER
    PHYSICIAN BARRIER GLOVE, SURGICAL
    MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE

    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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