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510(k) Data Aggregation

    K Number
    K071122
    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
    Manufacturer
    XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
    Date Cleared
    2007-12-12

    (233 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K932054
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 801.VZ, and meets all requirements of ASTM Standard D5250-06

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powdered Vinyl Exam Glove, Yellow Color:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from ASTM D5250-06, FDA 1000 ml Watertight Test, Biocompatibility testing)Reported Device Performance
    Physical and Dimensions Testing: Meets requirements as per ASTM D5250-06. (Inspection level S-2, AQL 4.0)"All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0."
    Watertight Test (Pinhole): Meets requirements as per FDA 1000 ml Watertight Test based on ASTM D-5151-06. (Sampling AQL 2.5, Inspection level I)"The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements."
    Primary Skin Irritation: No primary skin irritant reactions."Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant..."
    Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions."...or sensitization reactions."

    2. Sample Size Used for the Test Set and Data Provenance

    • Physical and Dimensions Testing:
      • Sample Size: Not explicitly stated as a numerical value for each test. Instead, it refers to an "Inspection level S-2, AQL 4.0" which dictates the sampling plan based on the lot size.
      • Data Provenance: Not explicitly stated for these tests, but the manufacturer is in China. The testing was likely conducted by the manufacturer or a contracted lab. It is retrospective, as the data is presented for a device already manufactured.
    • Watertight Test (Pinhole):
      • Sample Size: Not explicitly stated as a numerical value for each test. It refers to "samplings of AQL 2.5, Inspection level I" which dictates the sampling plan based on the lot size.
      • Data Provenance: Not explicitly stated, but likely the same as above (retrospective, probably China-based testing facility).
    • Primary Skin Irritation and Skin Sensitization:
      • Sample Size: Not specified for these biological tests.
      • Data Provenance: Not specified, but likely proprietary testing conducted by or for the manufacturer. It is retrospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This type of information is not applicable to this device and its testing. The "ground truth" for a medical glove is established through objective physical and chemical testing against established standards (ASTM standards, FDA watertight tests) and biocompatibility studies. It does not involve human expert interpretation or diagnosis for establishing a "ground truth" like in imaging or diagnostic AI.

    4. Adjudication Method for the Test Set

    This is not applicable. The nature of the testing (physical properties, watertight integrity, biocompatibility) does not require an adjudication method as would be used for subjective assessments or expert consensus in, for example, medical imaging studies. The results are objective measurements or categorical observations (e.g., irritation present/absent).

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    This is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply here.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

    This is not applicable. This device is a physical medical product (a glove), not an algorithm or AI system.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance is established by:

    • Objective Measurement against ASTM Standards: For physical properties and dimensions (e.g., tensile strength, elongation, dimensions).
    • Objective Test Results: For watertight integrity (pinhole test).
    • Biocompatibility Testing Results: For primary skin irritation and sensitization, following established test protocols for biological evaluation of medical devices.

    8. The Sample Size for the Training Set

    This is not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable. Since there is no training set, there is no ground truth to be established for it.

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