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510(k) Data Aggregation

    K Number
    K110224
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE
    Manufacturer
    WEIFANG BEIHAI COLOR PRINTING PACKAGGING CO., LTD
    Date Cleared
    2011-03-18

    (52 days)

    Product Code
    LYZ
    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

    A Synthetic Vinyl 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

    Synthetic Vinyl Examination Glove, Powder Free

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a "Synthetic Vinyl Examination Glove, Powder Free." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study design, or performance metrics for the device itself.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, and it outlines the regulatory requirements the manufacturer must comply with.

    Therefore, I cannot extract the requested information from this document. The questions you've asked are typically addressed in the submission's supporting data (e.g., performance testing reports), which are not included in this FDA 510(k) clearance letter.

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