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510(k) Data Aggregation

    K Number
    K021119
    Device Name
    POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM
    Manufacturer
    WRP ASIA PACIFIC SDN. BHD.
    Date Cleared
    2002-07-05

    (88 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K960416
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

    Device Description

    The device in this 510(k) submission is the Powdered Brown Latex Surgical Gloves. Sterile which is made of natural rubber latex. These gloves are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

    AI/ML Overview

    This document describes the 510(k) submission for "Powdered Brown Latex Surgical Gloves, Sterile" by WRP Asia Pacific Sdn Bhd. The submission focuses on claims related to expiration date and protein content.

    Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Barrier properties, physical and mechanical properties, packaging integrity, and sterility of the gloves maintained for the duration of the claimed shelf-life (i.e., 5 years)."Based on the results obtained through out the Stability Test, it can be concluded that the Powdered Brown Latex Surgical Gloves, Sterile produced by WRP Asia Pacific Sdn Bhd has demonstrated that the barrier properties, physical and mechanical properties, packaging integrity and sterility of the gloves are maintained for the duration of the claimed shelf-life (expiration date, i.e. 5 years)."
    Protein content level below 50 µg/g."Also, based on the protein content test report, the protein level of the gloves is well below 50 us/g and supports our protein content labeling claim."

    Note: While the company claims the device meets the 5-year shelf life, a later FDA letter (Page 4) indicates that the data submitted was "inadequate to support a 5 year shelf life" and that including this claim would result in the products being considered "misbranded." This highlights a discrepancy between the sponsor's claims and the FDA's assessment regarding the shelf-life acceptance criterion.

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

    • Sample Size: The document does not specify the exact sample size used for the Stability Test or the Protein Content Test. It only refers to "results obtained through out the Stability Test" and a "protein content test report."
    • Data Provenance: The tests were conducted by WRP Asia Pacific Sdn Bhd, a company located in Malaysia. The stability study and protein content tests would be considered prospective as they are performed to gather data to support specific claims over time or at the time of manufacturing.

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

    This information is not provided in the document. The tests performed (stability, protein content) are laboratory-based and do not typically involve human expert adjudication in the way medical imaging or diagnostic devices would. The "ground truth" for these tests would be established by the standardized testing protocols and measurements themselves, not expert consensus.

    4. Adjudication Method for the Test Set

    This is not applicable as the tests are laboratory-based measurements (e.g., tensile strength, barrier integrity, protein quantification) and do not involve human interpretation or adjudication in the context of diagnostic performance.

    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. This submission is for medical gloves, a physical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

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

    This is not applicable. This submission is for medical gloves, a physical device, and does not involve an algorithm.

    7. The Type of Ground Truth Used

    • For the Shelf-Life Claim (Barrier Properties, Physical & Mechanical Properties, Packaging Integrity, Sterility): The ground truth is based on objective measurements and standardized tests defined by relevant industry standards (e.g., ASTM, ISO for glove properties and sterility testing) conducted over the stated shelf-life duration. The document states "results obtained through out the Stability Test" are the basis.
    • For the Protein Content Claim: The ground truth is based on objective laboratory quantification of protein levels using a specific test method. The document mentions a "protein content test report."

    8. The Sample Size for the Training Set

    This is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI development. The "training" for such a product would be its manufacturing process and quality control, not data-driven model training.

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

    This is not applicable for the same reasons as point 8.

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