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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: LYZ FDA class 1

    Vinyl Patient Examination Glove

    General Hospital

    View full classification →

    The Vinyl Patient Examination Glove (product code LYZ) is a disposable device made of poly(vinyl chloride) intended to be worn on the hand during medical examinations to provide a barrier against potentially infectious materials and other contaminants, suitable for patients or clinicians with latex allergies, and may or may not contain a trace amount of residual powder. Regulated under 21 CFR 880.6250 and classified as a Class 1 device, it falls under the General Hospital specialty and is eligible for third-party review. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
    Disposable Vinyl Examination Gloves
    Powder-Free Vinyl Exam Gloves, clear
    Disposable Vinyl Examination Gloves
    Vinyl examination gloves
    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
    Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
    Disposable Vinyl Examination Gloves
    DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
    Disposable, vinyl examination gloves, Yellow
    Disposable Vinyl Examination Glove
    Vinyl Co-Polymer Powder-free Examination Gloves, Black
    Vinyl/Nitrile Blend Exam Glove
    Vinyl Examination Gloves
    Vinyl Powder Free Examination Glove
    Vinyl Exam Gloves
    NBR Synthetic Nitrile Examination Gloves
    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
    Vinyl Examination Gloves
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Disposable Vinyl/Nitrile Blend Medical Examination Gloves
    Synthetic Nitrile Examination Gloves
    Powder Free Vinyl Examination Gloves
    Vinyl Examination Gloves(Yellow)
    Disposable Vinyl Examination Gloves
    Synthetic Vinyl Examination Gloves
    Vinyl Glove
    Disposable Vinyl Nitrile Synthetic Gloves Powder Free
    Disposable Synthetic Vinyl Nitrile Examination Glove
    Vinyl compound examination gloves
    Disposable Vinyl Nitrile Synthetic Gloves Powder Free
    Vinyl Patient Examination Gloves
    Powder Free Vinyl Patient Examination Gloves
    Medical PVC Examination Gloves
    Synthetic Vinyl Examination Gloves
    Disposable Vinyl Examination Glove
    Disposable Vinyl Examination Gloves
    Disposable Synthetic Examination Gloves
    NitriTec Vinyl Glove Powder Free Blue
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Powder Free Vinyl Patient Examination Gloves
    Single-use medical poly (vinyl chloride) examination glove
    Vinyl Examination Gloves(Yellow)
    Disposable Vinyl Examination Gloves
    Vinyl Examination Gloves (Yellow)
    Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
    Disposable Vinyl Glove
    Disposable Vinyl Glove
    Medline Glide-On 3G Vinyl Examination Gloves

    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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