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510(k) Data Aggregation

    K Number
    K014077
    Device Name
    POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT
    Date Cleared
    2002-02-04

    (55 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K001128
    Why did this record match?
    Reference Devices :

    K001128

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

    A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

    A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.

    AI/ML Overview

    The provided document is a 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powder Free (Blue) Nitrile Patient Examination Gloves. This product is a Medical Device, not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML specific aspects (like multi-reader multi-case studies, standalone performance, training/test sets, and ground truth establishment) is not applicable to this submission.

    However, I can extract the acceptance criteria and the results of the non-clinical tests performed to demonstrate substantial equivalence, which is the analogous information for this type of device.

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria / Test PerformedStandard / RequirementReported Device Performance / Result
    Physical and Dimensions Testing (for glove production)ASTM-D-6319-00a1, Inspection Level S-2, AQL 4.0Meets all requirements
    FDA 1000 mL Water Fill Test (for pinholes)AQL 2.5, Inspection Level G-1Meets these requirements
    Primary Skin IrritationN/A (implied standard for biocompatibility)No primary skin irritant
    Skin Sensitization (allergic contact dermatitis)N/A (implied standard for biocompatibility)No sensitization reactions
    Residual Powder Test (for "powder-free" claim)ASTM D6124-01 (for Starch),
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