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510(k) Data Aggregation

    K Number
    K162259
    Device Name
    DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Manufacturer
    ZIBO DAIYANG PLASTIC COMPANY
    Date Cleared
    2016-12-21

    (132 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K091663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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

    The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

    AI/ML Overview

    The provided document is a 510(k) summary for the "DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. A table of acceptance criteria and the reported device performance:

    CharacteristicsStandard / Acceptance CriteriaReported Device Performance (DAIYANG Powder Free Vinyl Patient Examination Gloves)Predicate Device Performance (K091663)Result of Comparison (DAIYANG vs. Predicate)
    Dimension:ASTM D 5250-06(Reapproved 2011)Meets ASTM D5250-06Similar
    Length≥230mm231-241mm232-240mmSimilar
    Width (Small)80-90 mm81-8981-87Similar
    Width (Medium)90-100mm93-9993-98Similar
    Width (Large)100-110mm102-110102-109Similar
    Width (X Large)110-120 mm111-1119 (likely typo, should be 111-119)113-118Similar
    Thickness (Fingertip)≥0.05mm0.05-0.100.08-0.11Similar
    Thickness (Palm)≥0.08mm0.09-0.130.10-0.12Similar
    Physical Properties:ASTM D 5250-06(Reapproved 2011)Before aging/after aging: Elongation ≥300%, Tensile Strength ≥ 14MPaSimilar
    Tensile strength≥11MPa (Before & After aging)15-25 MPa15-20 MPaSimilar
    Elongation rate≥300% (Before & After aging)340-410%350-420%Similar
    Freedom from pinholes21 CFR 800.20 Passed Standard Acceptance Criteria; ASTM D5250-06; ASTM D5151-06Holes at Inspection Level I AQL2.5Holes at Inspection Level I AQL2.5Similar
    Powder ResidualASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011). Meets
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