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510(k) Data Aggregation

    K Number
    K222498
    Device Name
    Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
    Manufacturer
    Humanwell Healthcare Group Medical Supplies Co., Ltd.
    Date Cleared
    2022-10-26

    (69 days)

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

    Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

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

    The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.

    AI/ML Overview

    This request asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is an FDA 510(k) clearance letter for Medical Examination Gloves (Nitrile). This type of device is a low-risk product and its clearance documentation does not involve AI-driven diagnostics, clinical trials, or the detailed study methodologies (like blinding, sample sizes for test/training sets, expert adjudication, MRMC studies) that would be present for a complex medical software device.

    The information provided pertains to the physical and chemical properties of examination gloves, focusing on:

    • Biocompatibility: Tests for irritation, sensitization, and acute systemic toxicity.
    • Performance Testing (Physical): Dimensions, tensile strength, elongation, freedom from holes, and residual powder.

    Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," etc.) are not applicable to the documentation for a medical glove.

    I will interpret the request based on the actual content related to the medical gloves, explaining the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in that context.

    Device: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
    Product Code: LZA
    Regulation Number: 21 CFR 880.6250 - Non-Powdered Patient Examination Glove
    Regulatory Class: Class I, reserved

    1. Table of Acceptance Criteria and the Reported Device Performance

    The "study" in this context refers to non-clinical laboratory testing of the glove's physical, chemical, and biological properties.

    Biocompatibility Testing:

    TestPurposeAcceptance CriteriaReported Device Performance (Results)
    Irritation (ISO 10993-10)To verify that the proposed device extract is non-irritating.Under the conditions of the study, not an irritant.Pass
    Sensitization (ISO 10993-10)To verify that the proposed device extract is non-sensitizing.Under the conditions of the study, not a sensitizer.Pass
    Acute Systemic Toxicity (ISO 10993-11)To verify that the proposed device extract is non-toxic.Under the conditions of the study, the device is non-toxic.Pass

    Physical Performance Testing (against ASTM D6319-19 and other relevant standards):

    TestPurposeAcceptance CriteriaReported Device Performance (Results)
    Dimensions (Width, Length, Thickness - Palm/Finger)To evaluate the physical dimension of the glove.Width: 70mm min; Length: 220mm min; Palm: 0.05mm min; Finger: 0.05mm min.Pass: 76mm min width, 234mm min length, Palm: 0.08mm min, Finger: 0.09mm min
    Physical Properties (Tensile Strength & Elongation)To evaluate the tensile strength and ultimate elongation before and after aging.Tensile Strength: Before Aging $\geq$ 14 MPa, After Aging $\geq$ 14 MPa. Elongation: Before Aging 500% min, After Aging 400% min.Pass: Tensile Strength: Before Aging 24.44 MPa, After Aging 27.21 MPa. Elongation: Before Aging 513%, After Aging 541%.
    Freedom from Holes (ASTM D5151-19)To detect holes in the gloves.No leakage at sampling level of G-1, AQL 2.5.Pass: No leakage, 80 of 80 passed of each size.
    Residual Powder (ASTM D6124-06)To detect the powder residue in the glove.
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