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    K Number
    K052214
    Device Name
    PRE-POWDERED STERILE EXAM GLOVES
    Manufacturer
    KANAM LATEX INDUSTRIES PVT. LTD.
    Date Cleared
    2005-09-13

    (29 days)

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

    PRE-POWDERED STERILE EXAM GLOVES

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

    A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Kana Latex Industries Pvt. Ltd. regarding "Pre-Powdered Sterile Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory approval document, affirming that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general controls under the Food, Drug, and Cosmetic Act.

    Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study information, or expert ground truth based on the provided input.

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