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510(k) Data Aggregation

    K Number
    K233182
    Device Name
    Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
    Manufacturer
    Zibo Kaiyue Mould Technology Co., Ltd
    Date Cleared
    2023-12-15

    (78 days)

    Product Code
    LZA
    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

    The Powder-Free Nitrile 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 Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for "Powder Free Nitrile Examination Gloves." These documents do not contain information related to software or AI-powered medical devices. Therefore, I cannot extract details about acceptance criteria or supporting studies for such a device.

    The information you've requested (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in documentation for AI/Software as a Medical Device (SaMD) products, reflecting their performance evaluation.

    This submission is for a Class I medical device (non-powdered patient examination glove), which is a physical product and does not involve AI or algorithms requiring the type of performance study details you've outlined.

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