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510(k) Data Aggregation

    K Number
    K972104
    Device Name
    LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
    Manufacturer
    SHINEMOUND ENTERPRISE, INC.
    Date Cleared
    1997-08-15

    (72 days)

    Product Code
    LYZ
    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 Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Powdered Vinyl Synthetic Examination Gloves

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA to Shinemound Enterprise, Incorporated, concerning "Powdered Vinyl Synthetic Examination Gloves."

    The provided text is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets criteria.

    Therefore, I cannot provide the requested information. The document solely states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the indicated use (as a medical disposable glove worn by healthcare personnel to prevent contamination).

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