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510(k) Data Aggregation

    K Number
    K210253
    Device Name
    Best Glove-Latex Powder Free Examination Glove
    Manufacturer
    Bestsafe Glove CO., LTD.
    Date Cleared
    2021-11-05

    (280 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bestsafe Glove CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color is added) and are powder free.
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