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510(k) Data Aggregation

    K Number
    K982901
    Device Name
    LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1998-12-21

    (126 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 :

    LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED

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

    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    VitalCare Exam Gloves (Latex), Paude

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for VitalCare Latex Exam Gloves, Powdered, and it primarily focuses on the regulatory clearance process and the device's substantial equivalence to legally marketed predicate devices.

    The letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
    • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    The document confirms the device's classification and allows its marketing, but it does not provide the detailed study results or acceptance criteria you are asking for.

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