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510(k) Data Aggregation

    K Number
    K994206
    Device Name
    SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
    Manufacturer
    SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2000-02-07

    (55 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, Beige color (Sensi-Pro)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Vinyl Synthetic Examination Gloves, Beige color (Brand Name: Sensi-Pro)". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is an approval for the device based on its substantial equivalence to a predicate device already on the market, not a report of a new study designed to prove specific performance metrics.

    Therefore, I cannot extract the requested information from the provided text. The document confirms the FDA's decision regarding the device's market eligibility but does not detail the technical studies, acceptance criteria, or performance data that would generally be part of a submission proving the device's technical capabilities.

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