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510(k) Data Aggregation

    K Number
    K992175
    Device Name
    EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
    Manufacturer
    ULTRAWIN SDN BHD
    Date Cleared
    1999-09-24

    (88 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Extra-Care Powder Free Latex Patient Examination Glove - Polymer Coated

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a patient examination glove, confirming its substantial equivalence to a predicate device. It does not contain details about specific performance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for the device.

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