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510(k) Data Aggregation

    K Number
    K974114
    Device Name
    DASH, VITAL GARD
    Manufacturer
    DASH MEDICAL GLOVES SDN BHD
    Date Cleared
    1997-12-18

    (48 days)

    Product Code
    LZA
    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

    A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) clearance for "Dash, 'Vital Gard' Powderfree Blue Nitrile Examination Gloves." This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML medical device.

    The document is a clearance letter for a medical glove, which is a physical product, not a software or AI/ML device. Therefore, the concepts outlined in the request (such as acceptance criteria for AI performance, training/test sets, ground truth establishment by experts, MRMC studies) are not applicable to the content of this FDA letter.

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