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510(k) Data Aggregation

    K Number
    K221424
    Device Name
    Sterile Surgical Powder Free Latex Glove
    Manufacturer
    New Era Medicare Sdn. Bhd.
    Date Cleared
    2023-01-26

    (255 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Sterile Surgical Powder Free Latex Glove

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

    Sterile Surgical Powder Free Latex Glove is a disposable device intended for medical purposed that is worn on by operating room personnel to protect a surgical wound from contamination.

    Device Description

    Sterile Surgical Powder Free Latex Glove

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Sterile Surgical Powder Free Latex Glove," indicating that the device has been found substantially equivalent to a predicate device.

    The information primarily consists of:

    • FDA 510(k) Clearance Details: Device name, applicant, regulation number, product code, and clearance date.
    • Regulatory Information: References to general controls, other regulations (like registration, labeling, medical device reporting), and contact information for FDA assistance.
    • Indications for Use: A description of how the surgical glove is intended to be used.

    There is no mention of specific acceptance criteria, performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

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