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510(k) Data Aggregation

    K Number
    K972757
    Device Name
    ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
    Manufacturer
    SHIELD GLOVES MANUFACTURER (M) SDN BHD
    Date Cleared
    1997-10-29

    (98 days)

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

    This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ROYAL SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/PropertyAcceptance CriteriaReported Device Performance
    Dimension
    X-Small (Width)70 mm +/- 10 mm70 - 75 mm
    Small (Width)80 mm +/- 10 mm80 - 85 mm
    Medium (Width)90 mm +/- 10 mm90 - 97 mm
    Large (Width)100 mm +/- 10 mm105 - 100 mm
    Length (All Sizes)230 mm minimum240 mm minimum
    Thickness - Finger0.08 mm minimum0.08 mm minimum
    Thickness - Palm0.08 mm minimum0.08 mm minimum
    Physical Properties
    Tensile Strength (Before Aging)14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile)15.6 MPa
    Tensile Strength (After Aging)14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile)14.5 MPa
    Ultimate Elongation (Before Aging)700% (ASTM D3578-95); 500% (ASTM Draft Nitrile)650% (Meets ASTM Draft Nitrile, does not meet ASTM D3578-95)
    Ultimate Elongation (After Aging)500% (ASTM D3578-95); 400% (ASTM Draft Nitrile)575%
    Water Tight TestMeets FDA Water Leak Test Requirements (implied: very low leakage rate, typically
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