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510(k) Data Aggregation

    K Number
    K971200
    Device Name
    W.A.
    Manufacturer
    W.A. RUBBERMATE CO., LTD.
    Date Cleared
    1997-08-29

    (150 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 medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Powder Free Latex Patient Examination Gloves

    AI/ML Overview

    This document, a 510(k) premarket notification from the FDA, deals with the regulatory clearance of "Powder Free Latex Patient Examination Gloves". It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a study demonstrating the device's performance against specific acceptance criteria.

    Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text. The document confirms the device's clearance for marketing, but does not detail performance studies.

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