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510(k) Data Aggregation

    K Number
    K050598
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
    Manufacturer
    SMART GLOVE CORP. SDN BHD
    Date Cleared
    2005-04-07

    (29 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K020598
    Why did this record match?
    Reference Devices :

    K020598

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.

    Device Description

    Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue)

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)". It does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Instead, the letter establishes that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed, subject to general controls. It also outlines regulatory requirements, but it does not detail any specific performance acceptance criteria or a study report.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
    2. Sample sized used for the test set and the data provenance: This information is not present in the document because no specific study results are detailed.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
    4. Adjudication method: This information is not present in the document.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
    6. If a standalone performance (algorithm only) study was done: This information is not present in the document, as it pertains to a physical medical device (gloves), not an algorithm.
    7. The type of ground truth used: This information is not present in the document.
    8. The sample size for the training set: This information is not present in the document.
    9. How the ground truth for the training set was established: This information is not present in the document.

    The document primarily focuses on the regulatory clearance process for a medical device (nitrile examination gloves) and its "Indications for Use," which states: "Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs."

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