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510(k) Data Aggregation

    K Number
    K052635
    Manufacturer
    Date Cleared
    2005-12-13

    (78 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A medical glove is a disposable device which is worn on the hand of healthcare personnel to prevent contamination between patient and examiner.

    Device Description

    Powdered Synthetic Vinyl Patient Examination Gloves, Yellow

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Powdered Synthetic Vinyl Patient Examination Gloves, Yellow." It primarily discusses the substantial equivalence determination for this medical glove and regulatory compliance.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for the test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method for the test set
    5. MRMC comparative effectiveness study details
    6. Standalone performance study details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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