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510(k) Data Aggregation

    K Number
    K070760
    Device Name
    POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
    Manufacturer
    DERMA CARE PLUS PRODUCTS LLC
    Date Cleared
    2007-06-07

    (79 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 non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.

    Device Description

    POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications that would allow for a response to the user's request. The document primarily focuses on regulatory approval and classification.

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