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510(k) Data Aggregation

    K Number
    K021521
    Device Name
    STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2002-07-02

    (53 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

    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Sterile Powder Free Latex Examination Gloves With Protien Claim : (50 micrograms/g Of Gloves.or less)

    AI/ML Overview

    The provided document does not contain information about the acceptance criteria or a study that proves a device meets such criteria.

    The document is a letter from the Food and Drug Administration (FDA) to Smart Glove Corporation Sdn. Bhd. regarding the substantial equivalence determination for their "Sterile Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)".

    It is a regulatory approval letter, not a technical report detailing performance criteria or study results.

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