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510(k) Data Aggregation

    K Number
    K112005
    Device Name
    NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2012-03-21

    (252 days)

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

    UG HEALTHCARE (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Non-Sterile, Powder-Free, Latex Examination Gloves, Green and with Protein Labeling Claim
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    K Number
    K112012
    Device Name
    NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
    Date Cleared
    2012-03-21

    (252 days)

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

    UG HEALTHCARE (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. 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. Summary of Technological Characteristics: Cuff: Beaded Material: Nitrile Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003 Physical Properties: Overall Length: 240 mm minimum Width: 95 mm minimum (for medium glove) Thickness: .05 mm minimum BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum Special Properties: None Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case Sizes: XS — XL
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    K Number
    K062688
    Device Name
    POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
    Date Cleared
    2006-11-30

    (83 days)

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

    UG HEALTHCARE (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
    Device Description
    Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05. Powder Residue: Maximum 2mg/glove Cuff: Beaded Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000 Overall Length: 240 mm minimum Width: 95 mm minimum (for medium glove) Palm Thickness: 0.13 to 0.18mm (at center of palm) Finger Thickness: 0.15 to 0.20 mm (at 15mm from tip of center finger) Cuff Thickness: 0.10 to 0.15 mm (at 40mm from the beaded end) BEFORE AGING Tensile Strength: 21.0 Mpa minimum BEFORE AGING Ultimate Elongation: 700% minimum BEFORE AGING Pinhole AQL 1.5 minimum AFTER AGING 16.0 Mpa minimum AFTER AGING 500% minimum AFTER AGING 1.5 minimum Special Properties: Black Colorant Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case Sizes: XXS — XXL
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