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510(k) Data Aggregation

    K Number
    K253160

    Validate with FDA (Live)

    Device Name
    Syntex Exam Gloves
    Manufacturer
    Basic Medical Technology, Inc.
    Date Cleared
    2026-01-23

    (119 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K220442
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Syntex Exam Gloves is a Class I patient examination glove, that made from synthetic Butadiene-acrylonitrile latex. They are natural latex color, non-sterile, powder-free, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.

    The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility.

    AI/ML Overview

    N/A

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