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510(k) Data Aggregation

    K Number
    K062950
    Device Name
    POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2006-12-21

    (83 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    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 Powder Free Surgeon's Glove made of synthetic material. It is intended to be worn by health.care personnel, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    Powder Free Sterile Nitrile Surgical Gloves (Blue)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for Powder Free Sterile Nitrile Surgical Gloves (Blue). It does not contain information about acceptance criteria for a study, device performance, sample sizes, expert involvement, or grand truth. Therefore, I cannot answer the questions based on the provided text.

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