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510(k) Data Aggregation

    K Number
    K990186
    Date Cleared
    1999-06-21

    (152 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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 a disposable device intended for A pacience chaminat is worn on the examinaer'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 Nitrile Patient Examination Glove, 80 LZA and meets all requirements of ASTM D3578-95.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Shanghai INTCO Plastic Rubber Products Co., Ltd. Synthetic Powderfree Nitrile Patient Examination Gloves:

    Acceptance Criteria and Device Performance:

    The provided document details the acceptance criteria based on established ASTM and FDA standards for patient examination gloves. The device is reported to meet these criteria.

    Acceptance CriteriaReported Device Performance
    Material Standard: Conformance to ASTM D3578-95The device "conforms fully to ASTM D-3578-95 standards."
    Physical and Dimensions Testing: Meets requirements as per ASTM D3578-95, 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."
    Pinhole (Water Leak) Test: FDA 1000 ml. Water Fill test, AQL 2.5, Inspection Level S-4"The FDA 1000 ml. Water Fill test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements." and "meets pinhole FDA requirements."
    Biocompatibility - Primary Skin Irritation: No primary skin irritant reactions"Primary Skin Irritation...testing was conducted with results showing no primary skin irritant...reactions."
    Biocompatibility - Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions"Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions."
    Powder Content: Negative result on USP Iodine Test (absence of powder)"The USP Iodine Test has been employed to show that no powder is used in the process (negative results)."
    Labeling Claims: No special labeling claims, no 'hypoallergenic' claim"There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." and "meets...labeling claims as shown by data in Section 7."
    Regulatory Conformance: Conforms to applicable 21 CFR references (e.g., 21 CFR 880.6250)"conform fully to...applicable 21 CFR references."

    Study Details:

    It's important to note that this submission is for a medical device (patient examination gloves), and the "study" here refers to the non-clinical and "clinical" (biocompatibility) tests performed to demonstrate substantial equivalence to predicate devices, rather than a clinical trial in the traditional sense for diagnostic or therapeutic devices.

    1. Sample size used for the test set and the data provenance:

      • Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0" (The exact number of units sampled is not specified but is determined by the AQL and inspection level from ASTM tables).
      • FDA 1000 ml. Water Fill test: "samplings of AQL 2.5, Inspection Level S-4" (Again, the exact number is not explicitly stated but is derived from the AQL and inspection level).
      • Primary Skin Irritation and Skin Sensitization: The number of subjects or samples for these biocompatibility tests is not provided in the summary.
      • Data Provenance: The tests were conducted by the manufacturer, Shanghai INTCO Plastic Rubber Products Co., Ltd. The document does not specify country of origin for the samples, but implies they are from their manufacturing process in China. These tests are retrospective to the submission date.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This question is not directly applicable in the context of device testing for examination gloves. The "ground truth" is established by adherence to the objective, predefined criteria and methodologies within the ASTM and FDA standards themselves for physical properties, dimensions, and biocompatibility. There isn't a "ground truth" established by human experts in the same way there would be for an AI diagnostic device evaluating images. Testing is performed by qualified laboratory personnel following strict protocols.
    3. Adjudication method for the test set:

      • Not applicable. Testing is objective and follows standardized protocols. Results are compared directly to the specified acceptance criteria of ASTM D3578-95 and FDA guidelines, not against expert consensus.
    4. 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:

      • Not applicable. This device is a manual medical device (examination glove), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance is relevant.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable, as this is not an algorithm-based device.
    6. The type of ground truth used:

      • The "ground truth" for this device's performance is the adherence to established industry standards (ASTM D3578-95) and regulatory requirements (FDA 1000 ml. Water Fill test, 21 CFR, biocompatibility guidelines). This is a form of objective measurement against predefined specifications.
    7. The sample size for the training set:

      • Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set." The manufacturing process itself (e.g., using a polyurethane coating instead of powder) is designed to meet criteria, not "trained."
    8. How the ground truth for the training set was established:

      • Not applicable, as there is no training set for this type of device.
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