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510(k) Data Aggregation

    K Number
    K223250
    Device Name
    Disposable Nitrile Examination Glove
    Manufacturer
    Yangzhou Saraguard Medical Supplies Co.,Ltd.
    Date Cleared
    2023-01-19

    (90 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203593,K171422
    Why did this record match?
    Reference Devices :

    K203593

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

    The disposable nitrile medical examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free nitrile examination gloves. The subject device is available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.

    Here's the information extracted and formatted as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodPurposeAcceptance CriteriaReported Device Performance
    ISO 10993-23:2021 Tests For IrritationTo determine if device is a skin irritantThe device must be a non-irritantPass
    ISO 10993-10:2021 Tests For Skin SensitizationTo determine if device is a skin sensitizerThe device must be a non-sensitizerPass
    ISO 10993-5:2009 Tests For In Vitro CytotoxicityTo determine if the device is potential toxicity to L-929 cells.The device must be a non toxicity.Cytotoxic (Note: The summary later states this is the same as the reference device and does not affect substantial equivalence due to acute systemic toxicity results.)
    ISO 10993-11:2017 Tests for Acute systemic toxicityTo determine if the device will cause acute systemic toxicity in vivoThe device must be a Non-acute systemic toxicityPass
    ASTM D6319 (Physical Dimensions)Physical Dimensions TestLength(mm): S:≥220; M/L/XL:≥230; Width(mm): XS: 70±10mm; S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05Length: > 240/Pass (for all sizes)
    Width (Blue color): XS: 74-76 /Pass; S: 82-86 /Pass; M: 95-97/ Pass; L: 104-106/ Pass; XL:115-117/ Pass
    Width (White Color): XS: 73-76 /Pass; S: 80-87 /Pass; M: 100-103/ Pass; L: 104-106/ Pass; XL:114-117/ Pass
    Thickness (Blue color): XS: Finger:0.10-0.12/Pass, Palm: 0.06-0.10/Pass; S: Finger: 0.09-0.12/Pass, Palm:0.07-0.09/Pass; M: Finger: 0.08 -0.12/Pass, Palm: 0.07-0.09/Pass; L: Finger: 0.09-0.12/Pass, Palm: 0.06-0.09/Pass; XL: Finger: 0.11-0.12/Pass, Palm: 0.06-0.09/Pass
    Thickness (White Color): Details for XS are visible, other sizes indicated but not fully detailed, likely indicating pass.
    ASTM D6319 (Physical Properties)Tensile StrengthBefore Aging: ≥14MPa, After Aging: ≥14MPaBefore Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass
    After Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass
    ASTM D6319 (Physical Properties)Ultimate ElongationBefore Aging: ≥500%, After Aging: ≥400%Before Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass
    After Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass
    ASTM D6319 / ASTM D5151-19Freedom from HolesG-1, AQL 2.5Complies with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implies Pass)
    ASTM D6319-19Powder Content
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