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510(k) Data Aggregation

    K Number
    K220697
    Device Name
    Nitrile Patient Examination Gloves, Powder Free
    Manufacturer
    Lalan Rubbers (Pvt) Ltd
    Date Cleared
    2022-09-15

    (190 days)

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

    Lalan Rubbers (Pvt) Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile Patient Examination Gloves, Powder Free, are intended for medical purposes that are worn on the examiners' hands to prevent contamination between patient and examiner.
    Device Description
    The Nitrile Patient Examination Gloves, Powder Free are non-sterile, single use only, disposable, and powder free examination gloves. The glove is made of synthetic nitrile latex compound. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D 6319 - Standard specification for Nitrile Examination Gloves for Medical Application.
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