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510(k) Data Aggregation

    K Number
    K030993
    Device Name
    NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2003-06-12

    (76 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K000671
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A 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

    NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for "NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (

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