Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K091662
    Date Cleared
    2009-07-30

    (51 days)

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

    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.

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

    Powdered vinyl 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

    powdered vinyl patient examination gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text:

    Acceptance Criteria and Device Performance

    CharacteristicsStandardAcceptance CriteriaReported Device Performance
    DimensionASTM standard D 5250-06Meets requirements of ASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets requirements of ASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20Meets requirements of 21 CFR 800.20 (and FDA recognition number 2-87 for AQL)Meets
    Powder AmountASTM standard D 5250-06 and D6124-06 (and 21 CFR 800.20)
    Ask a Question

    Ask a specific question about this device

    K Number
    K091663
    Date Cleared
    2009-07-27

    (48 days)

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

    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.

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

    Powder free vinyl 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd. This is a medical device submission, and the "study" described is the testing conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant standards.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicsAcceptance CriteriaDevice Performance
    DimensionASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20 (Water leak test on pinhole AQL)Meets
    Powder ResidualASTM standard D 5250-06 and D6124-06
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1