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510(k) Data Aggregation

    K Number
    K991950
    Device Name
    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-08-12

    (64 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powder-Free) is a disposable glove made of synthetic rubber intended to be worn by operating personnel during surgical procedures to help prevent contamination between health-care personnel and the patient.

    Device Description

    disposable glove made of synthetic rubber

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for Laglove™ Brand Nitrile Surgical Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot answer the question based on the provided text.

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