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510(k) Data Aggregation

    K Number
    K031386
    Device Name
    LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
    Manufacturer
    LALAN GLOVES (PVT) LTD.
    Date Cleared
    2003-10-06

    (158 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LALAN GLOVES (PVT) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.
    Device Description
    A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.
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