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510(k) Data Aggregation

    K Number
    K112610
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
    Manufacturer
    INPRO TECHNOLOGY DEVICE FACTORY
    Date Cleared
    2011-12-05

    (89 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

    Synthetic Vinyl Examination Glove, Powder Free 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 Gloves, Powder-Free

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

    The document is a regulatory approval for a medical device (gloves) based on substantial equivalence to a predicate device, not on performance studies against specific acceptance criteria like those used for AI/ML algorithms.

    Therefore, I cannot provide the requested information. This document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test or training sets, nor data provenance.
    • Number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • Type of ground truth used.
    • Ground truth establishment for a training set.
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    K Number
    K111297
    Device Name
    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
    Manufacturer
    PREMIER MEDICAL GLOVES FACTORY
    Date Cleared
    2011-06-16

    (38 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

    Synthetic Vinyl Examination Glove, Powder Free 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 Gloves, Powder-Free

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.

    This document does not contain any information about:

    • Acceptance criteria for device performance
    • A study proving the device meets acceptance criteria
    • Sample sizes for test or training sets
    • Data provenance
    • Ground truth establishment or type
    • Number or qualifications of experts
    • Adjudication methods
    • Multi-reader multi-case (MRMC) comparative effectiveness studies
    • Standalone algorithm performance studies

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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