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510(k) Data Aggregation

    K Number
    K162312
    Device Name
    Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
    Manufacturer
    SHEN WEI USA INC.
    Date Cleared
    2017-07-25

    (341 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K993876
    Why did this record match?
    Device Name :

    Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color

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

    The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

    Device Description

    Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

    The gloves are coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.

    The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of AI performance. Therefore, I cannot provide details on AI acceptance criteria, sample sizes for AI tests, expert qualifications, or MRMC studies.

    However, I can extract the acceptance criteria and device performance for the glove itself, as per the submitted documentation.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsStandardsDevice Performance
    DimensionsASTM D6319-10Meets Standard Requirements
    Physical Properties (Before/After Aging)ASTM D6319-10Meets Standard Requirements
    Freedom from pinholesASTM D6319-10 / ASTM D5151-11Meets Standard Requirements
    Biocompatibility (Primary Skin Irritation in Rabbits)ISO 10993-10:2010Not a skin irritant under the conditions of study.
    Biocompatibility (Dermal Sensitization)ISO 10993-10:2010Not a contact sensitizer under the conditions of the study.
    Powder Residue(Implied by standard and predicate)Meets Standard Requirements
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