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510(k) Data Aggregation

    K Number
    K051404
    Device Name
    B-CARE POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    B-CARE INDUSTRIES CO., LTD.
    Date Cleared
    2005-09-27

    (119 days)

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

    The B-Care Powder Free, Latex Examination Gloves is a disposable device intended for medical purposes that is worn on examiner's hands or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)

    Device Description

    B-Care Powder Free, Latex Examination Gloves

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding B-Care Powder Free, Latex Examination Gloves. It primarily addresses the substantial equivalence determination for a medical device and does not contain information about the acceptance criteria or a study proving that a device meets specific acceptance criteria.

    Therefore, I cannot provide the requested information based on the given document.

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