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510(k) Data Aggregation

    K Number
    K970115
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    PT MBF BUANA MULTICORPORA
    Date Cleared
    1997-08-15

    (214 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PT MBF BUANA MULTICORPORA

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

    Glove worn on hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device described as "Powder Free Latex Examination Gloves." As such, it does not contain any information regarding acceptance criteria, study data, or performance metrics typically associated with AI/ML-driven medical devices.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It does not refer to any studies proving performance against acceptance criteria in the way a modern AI/ML device submission would.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance for a physical medical product based on substantial equivalence, not on validating the performance of an algorithm.

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