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510(k) Data Aggregation

    K Number
    K992922
    Device Name
    SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
    Manufacturer
    SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    1999-10-06

    (37 days)

    Product Code
    LYZ
    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 disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Disposable Powdered Vinyl Synthetic Examination Gloves, White color (Sensi-Pro)

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for "Sensi-Pro, Disposable Powdered Vinyl Synthetic Examination Gloves." This document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as requested in the prompt. The letter merely acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot extract the requested information from the provided text.

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