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510(k) Data Aggregation

    K Number
    K101664
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    HEBEI EXCELLENT PLASTIC CO., LTD.
    Date Cleared
    2010-07-27

    (43 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032907
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powdered vinyl 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

    powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for K101664, based on the provided text:

    Reported Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06'Meets
    Physical PropertiesASTM standard D 5250-06'Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder AmountASTM standard D 5250-06'Meets
    Biocompatibility (Overall)ISO10993-10 (implied by "Meets requirements per... ISO10993-10")
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    K Number
    K101663
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    HEBEI EXCELLENT PLASTIC CO., LTD.
    Date Cleared
    2010-07-27

    (43 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder free vinyl 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

    powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the K101663 device, structured as requested:

    Acceptance Criteria and Device Performance

    CharacteristicsStandardAcceptance CriteriaReported Device Performance
    DimensionASTM standard D 5250-06Meets ASTM D5250-06 requirementsMeets
    Physical PropertiesASTM standard D 5250-06Meets ASTM D5250-06 requirementsMeets
    Freedom from pinholes21 CFR 800.20Meets 21 CFR 800.20 (Waterleak test on pinhole AQL)Meets
    Powder ResidualASTM standard D 5250-06 & D6124-06
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