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510(k) Data Aggregation

    K Number
    K051152
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
    Manufacturer
    ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2005-06-03

    (30 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

    AI/ML Overview

    This document is a 510(k) Premarket Notification summary for medical gloves, not a study of an AI device. As such, it does not contain the information requested in your prompt regarding AI device acceptance criteria and study details.

    However, I can extract the relevant information about the device performance and acceptance criteria for the medical gloves as presented in this document.

    1. A table of acceptance criteria and the reported device performance:

    CharacteristicsStandard / Acceptance CriteriaDevice Performance
    DimensionASTM standard D 5250-00e4Meets
    Physical PropertiesASTM standard D 5250-00e4Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder AmountASTM standard D 5250-00e4<10mg/dm2
    Biocompatibility (Primary Skin Irritation)Primary Skin Irritation in rabbitsPasses (Not a Primary Skin Irritation)
    Biocompatibility (Dermal Sensitization)Dermal sensitization in the guinea pigPasses (Not a Dermal Sensitization)

    Regarding the AI-specific questions (2-9), this document does not contain that information because it pertains to a medical glove, not an AI device.

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