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510(k) Data Aggregation

    K Number
    K982885
    Device Name
    PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
    Manufacturer
    SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    1998-12-04

    (109 days)

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

    PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between nations and examiner.

    Device Description

    VINYL EXAMINATION GLOVE (Pre-POWDERED)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Powdered Vinyl Patient Examination Glove." This document is a regulatory approval letter and does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the detailed aspects of a clinical study outlined in your request.

    Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence and marketing approval, not on the technical performance specifications or clinical study results of the glove.

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