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510(k) Data Aggregation

    K Number
    K973020
    Device Name
    PATIENT EXAMINATION POWDER-FREE GLOVES
    Manufacturer
    WEAR SAFE MALAYSIA SDN. BHD.
    Date Cleared
    1998-01-06

    (146 days)

    Product Code
    LYY
    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

    A patient Examination Powder-Free Chlorinated glove 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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" (K973020). It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, or in supporting documentation, not in the clearance letter.

    Therefore, I cannot fulfill your request for the specific information you asked for based on the provided text. The document confirms the regulatory approval of the device but offers no technical specifications or study details.

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