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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: LZC FDA class 1

    Medical Glove, Specialty

    General Hospital

    View full classification →

    The Specialty Medical Glove (product code LZC) is a disposable examination or surgical glove that may or may not contain residual powder and is worn on the hand or finger(s) for medical purposes to prevent contamination, with specialty claims such as chemotherapy drug handling or other specific applications beyond standard examination use. 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 Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
    JR Medic
    Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
    Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
    Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
    Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
    Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
    Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
    AspenMed+
    Disposable Medical Nitrile Examination Gloves (Non sterile)
    Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
    Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
    Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
    Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
    Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
    Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
    Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
    Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
    Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
    Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
    Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
    Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
    PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
    Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
    Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    Orange Non Sterile Powder Free Nitrile Examination Gloves
    Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
    BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
    Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
    POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
    HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
    Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
    NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
    DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
    BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
    NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
    POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
    POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
    POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL

    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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