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510(k) Data Aggregation

    K Number
    K220088
    Device Name
    Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Professional Latex Sdn Bhd
    Date Cleared
    2023-03-30

    (443 days)

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

    Professional Latex Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.
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    K Number
    K173053
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVE
    Manufacturer
    Professional Latex Sdn Bhd
    Date Cleared
    2018-06-06

    (251 days)

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

    Professional Latex Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
    Device Description
    Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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    K Number
    K171667
    Device Name
    Powder Free Nitrile Examination Glove
    Manufacturer
    Professional Latex Sdn Bhd
    Date Cleared
    2017-09-08

    (95 days)

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

    Professional Latex Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
    Device Description
    Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.
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