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510(k) Data Aggregation

    K Number
    K091770
    Device Name
    VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR
    Manufacturer
    SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.
    Date Cleared
    2010-04-06

    (294 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 patient examination glove is a disposable device intended for medical purpose that A partient chanination goss hands or finger to prevent contamination between patient and examiner.

    Device Description

    VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR

    AI/ML Overview

    This document is a letter from the FDA regarding a 510(k) premarket notification for "VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR." It is a regulatory approval document and does NOT contain information about acceptance criteria or a study that proves a device meets such criteria.

    Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on specific performance studies or acceptance criteria for the new device.

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