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510(k) Data Aggregation

    K Number
    K050765
    Device Name
    LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2005-04-08

    (15 days)

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

    N.S. UNI-GLOVES 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 the patient and the examiner.
    Device Description
    Lano-E Powder-Free Nitrile Examination Glove. Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A. Powder Residue: Maximum 2mg/glove. Material: Nitrile. Cuff: Beaded. Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
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    K Number
    K013163
    Device Name
    UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2002-01-22

    (123 days)

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

    N.S. UNI-GLOVES 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 the patient and the examiner.
    Device Description
    Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00 Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP. Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs. Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
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    K Number
    K010881
    Device Name
    UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2001-05-16

    (54 days)

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

    N.S. UNI-GLOVES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010879
    Device Name
    UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2001-05-10

    (48 days)

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

    N.S. UNI-GLOVES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000689
    Device Name
    UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2000-04-28

    (59 days)

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

    N.S. UNI-GLOVES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000688
    Device Name
    UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
    Manufacturer
    N.S. UNI-GLOVES SDN. BHD.
    Date Cleared
    2000-04-12

    (43 days)

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

    N.S. UNI-GLOVES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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