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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: KGO FDA class 1

    Surgeon'S Gloves

    General, Plastic Surgery

    View full classification →

    Surgeon's Gloves are disposable gloves made of natural rubber latex or synthetic polymers intended to be worn on the hands in surgical settings to provide a barrier against potentially infectious materials and other contaminants, protecting both the patient and the surgical team. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGO, regulated under 21 CFR 878.4460, within the General, Plastic Surgery medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Polyisoprene Surgical gloves
    Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
    Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
    GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
    PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
    Single-Use Latex Sterile Surgical Gloves (SG100)
    Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
    Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
    Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
    Powdered Free Sterile Natural Rubber Latex Surgical Gloves
    Polyisoprene Surgical Gloves
    Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
    Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
    Sterile Nitrile Surgical Gloves Powder Free
    Sterilized Latex Surgical Gloves
    Sterile Surgical Powder Free Latex Glove
    Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
    Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
    Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
    Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
    Disposable Sterilized Latex Surgical Gloves
    Sterile Latex Surgical Gloves Powder Free
    Sterile Latex Surgical Gloves Powder Free
    Nulife
    Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
    Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
    Sterile Latex Surgical Gloves Powder Free
    ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
    SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
    Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
    ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
    POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
    Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
    Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
    Polyisoprene Powder Free, Black Colour Surgical Gloves
    Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
    Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
    Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
    Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
    SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
    Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
    Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
    SensiCare PI and SensiCare PI Micro Surgical Gloves
    Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
    Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
    Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
    JR.MEDIK Latex Surgeon’s Gloves Powder Free
    SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V

    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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