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510(k) Data Aggregation

    K Number
    K200326
    Device Name
    Powder Free Nitrile Examination Glove (Aqua Green)
    Manufacturer
    Riverstone Resources SDN BHD
    Date Cleared
    2020-04-09

    (59 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K141579
    Why did this record match?
    Device Name :

    Powder Free Nitrile Examination Glove (Aqua Green)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

    Device Description

    The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance CriteriaReported Device Performance (Powder Free Nitrile Examination Glove (Aqua Green), K200326)
    Product CodeLZALZA
    Intended UseA powder free 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. The device is for over-the-counter use.Meets intended use description.
    Material UseNitrile compoundNitrile compound
    ColorN/A (not a criterion for equivalence, but noted as different from predicate)Aqua Green
    SterilityN/ANon sterile
    Single UseSingle usedSingle used
    DimensionsOverall Length: Min 230mm; Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm: Min 0.05 mm; Thickness at Finger Tip: Min 0.05 mm (Per ASTM D6319-10)Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
    Physical Properties (Before Aging)Tensile Strength: 14min MPa; Ultimate Elongation: 500min % (Per ASTM D6319-10)Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
    Physical Properties (After Aging)Tensile Strength: 14min MPa; Ultimate Elongation: 400min % (after 70ºC for 168 hrs @ 100ºC for 22 hrs) (Per ASTM D6319-10)Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these)
    Freedom from PinholesAQL 2.5, Inspection Level G-1 (Per ASTM D5151-06)Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1)
    Residual Powder
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