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510(k) Data Aggregation

    K Number
    K984040
    Device Name
    BLOSSOM POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    MEXPO INTL., INC.
    Date Cleared
    1999-01-13

    (62 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 :

    BLOSSOM POWDERED LATEX EXAMINATION GLOVES

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

    A medical glove is worn on the hand of health care and similar personnel and the patient, A medical glove is worn on one nation between health

    Device Description

    BLOSSOM TM Powdered Latex Examination Gloves

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter and the associated pages (sections 0, 1, and 2) do not contain any information about acceptance criteria or a study proving that a device meets those criteria.

    The document is an FDA 510(k) clearance letter for "Blossom Powdered Latex Examination Gloves." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Key information present in the document includes:

    • Device Name: Blossom Powdered Latex Examination Gloves
    • Applicant: Mexpo International, Incorporated
    • 510(k) Number: K984040
    • Regulatory Class: I
    • Product Code: LYY
    • Indications for Use: "A medical glove is worn on the hand of health care and similar personnel and the patient." (This is a generic description for medical gloves and not specific performance criteria).

    Therefore, I cannot provide the requested table or details about a study, as that information is not available in the given text.

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