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    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: LYY FDA class 1

    Latex Patient Examination Glove

    General Hospital

    View full classification →

    The Latex Patient Examination Glove (product code LYY) is a disposable device made of natural rubber latex intended to be worn on the hand during medical examinations and procedures to provide a barrier against potentially infectious materials and other contaminants, 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 subject only to general controls, 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 Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
    Latex Examination Glove Powder Free (Ocean Blue and Natural White)
    Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
    Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
    Powder-Free Latex examination gloves
    Non Sterile Powder Free Latex Examination Glove
    JR MEDIC
    Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
    Single-use medical latex examination gloves (LG100)
    Iconic Latex Glove
    Powder Free Latex Examination Glove, Non-Sterile
    Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
    Examination gloves-Type A(Latex gloves)
    TC Gloves
    Amazing+ Latex Examination Powder Free Gloves
    Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
    Non-sterile, Powder-Free Latex Examination Glove
    Latex Examination Gloves, Powder Free
    Goody Gloves, Wincare, TBG Gloves
    Comfortpro
    Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
    Best Glove-Latex Powder Free Examination Glove
    Latex Examination Powder Free Gloves
    Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
    Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
    Disposable Latex Powder Free Examination Gloves (Non-sterile)
    Palm Care Latex Examination Powder Free Gloves
    Blue Latex Examination Powder Free Gloves
    POWDER FREE LATEX EXAMINATION GLOVE
    SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
    Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
    LATEX EXAMINATION GLOVE POWDER FREE
    UniTex Non-Sterile, Powder-Free, Latex Examination Glove
    Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
    A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
    Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
    LATEX EXAMINATION GLOVE POWDER FREE
    Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)
    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
    Patient Examination Gloves
    LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
    LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
    POWDER FREE LATEX EXAMINATION GLOVES
    POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
    POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
    LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
    MULTIPLE NAME
    POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
    TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O

    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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