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510(k) Data Aggregation

    K Number
    K191292
    Device Name
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Manufacturer
    Anhui Powerguard Technology Co.,Ltd
    Date Cleared
    2019-11-05

    (175 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

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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

    The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CharacteristicAcceptance CriteriaReported Device Performance (K191292)
    Dimensions - LengthASTM D 5250-06 (Reapproved 2011): ≥ 230mm233-241mm
    Dimensions - WidthASTM D 5250-06 (Reapproved 2011):
    Small 80-90 mm
    Medium 90-100mm
    Large 100-110mm
    X large 110-120 mm84-88 mm
    94-98 mm
    103-109 mm
    114-117 mm
    Dimensions - ThicknessASTM D 5250-06 (Reapproved 2011):
    Fingertip ≥0.05mm
    Palm ≥0.08mmFingertip: 0.08-0.11mm
    Palm: 0.10-0.11mm
    Physical Properties (Tensile Strength)ASTM D 5250-06 (Reapproved 2011): ≥11MPa (Before & After aging)15-17 MPa (for "Physical Properties")
    Physical Properties (Elongation Rate)ASTM D 5250-06 (Reapproved 2011): ≥300% (Before & After aging)350-390% (for "Physical Properties")
    Freedom from PinholesASTM D5151-06 (Reapproved 2011): Holes at Inspection Level I, AQL2.5, Act/Re: 10/11Water leakage test: 3 noncompliance is allowed (This is a different test/criterion reported in the comparison table, but within the "similar" category for pinholes). The detailed result for the ASTM D5151-06 specific criterion is not explicitly stated as "Pass" or "Fail" in the result column, but the overall "similar" comparison implies conformity.
    Powder ResidualASTM D6124-06 (Reaffirmation 2011):
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