LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991949
    Device Name
    LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    1999-08-12

    (64 days)

    Product Code
    KGO,DAT
    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 (POWDERED)

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

    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber intended to be worn by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    LAGLOVE™ Brand Nitrile Surgical Gloves -Sterile (Powdered) is a disposable glove made of synthetic rubber.

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the "Laglove™ Brand Nitrile Surgical Glove-Trade Name: Sterile (Powdered)". As such, it does not contain information about acceptance criteria and a study proving a device meets those criteria.

    The core purpose of this document is the FDA's declaration of "substantial equivalence" of the device to previously marketed devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1