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510(k) Data Aggregation

    K Number
    K994222
    Device Name
    SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
    Manufacturer
    SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2000-02-07

    (54 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 Powder Free Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige Color (Brand Name: Sensi-Pro)". This document is a regulatory approval and does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in the prompt.

    Therefore, I cannot provide the requested information based on the given input text.

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