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510(k) Data Aggregation

    K Number
    K992979
    Device Name
    SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
    Manufacturer
    SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2000-02-09

    (159 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K021353,K021743,K021961,K022305
    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

    Powder-Free Synthetic Vinyl Examination Gloves, Yellow

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Powder-Free Synthetic Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot answer your request based on the provided text.

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