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510(k) Data Aggregation

    K Number
    K252075
    Manufacturer
    Date Cleared
    2025-10-17

    (107 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    The powder-free nitrile exam gloves are non-sterile, single-use, ambidextrous medical examination gloves made from nitrile butadiene rubber (NBR). They are blue, feature a beaded cuff, and are available in sizes S–XL. The gloves are not made with natural rubber latex.

    Their physical and performance characteristics meet all requirements of ASTM D6319-19. The gloves are powder-free and meet the requirements of ASTM D6124-06. Powder is not used during any stage of manufacturing. Rather, the gloves are manufactured using a non-chlorinated polyurethane (PU) inner coating to reduce surface friction and facilitate donning. More specifically, following the dipping phase, the gloves pass through gelling and pre-curing ovens to stabilize the film and control thickness and tactile responsiveness. The PU coating is applied to the inner (donning) surface and then dried and cured, producing a smooth, low-friction finish. Residual processing aids are removed through rinsing/drying steps, resulting in a stable, non-reactive donning surface. Automated cuff beading is then performed to enhance edge durability and ease of application.

    AI/ML Overview

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