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510(k) Data Aggregation

    K Number
    K010297
    Device Name
    SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
    Manufacturer
    MAXXIM MEDICAL
    Date Cleared
    2001-02-16

    (16 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K022095
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K983982
    Device Name
    SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
    Manufacturer
    MAXXIM MEDICAL
    Date Cleared
    1999-05-04

    (176 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K933062
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    The device in this 510(k) submission is the SensiCare™ Synthetic Powder-Free Surgical Glove (Classification number 79KGO). The SensiCare™ Synthetic Powder-Free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the SensiCare™ Synthetic Powder-Free Surgical Gloves.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material/Design: Sterile, synthetic rubber latex surgical gloveThe device described is the SensiCare™ Synthetic Powder-Free Surgical Glove, which is a sterile, synthetic rubber latex surgical glove. The only differences from the predicate are the use of synthetic polyisoprene instead of synthetic neoprene and variations processes and packaging.
    Barrier Protection: Intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.This is the intended use of the device, aligning with the definition of a surgeon's glove.
    ASTM D3577-98 Requirements: Meets requirements for sterility, freedom from holes, physical properties, and physical dimensions."The gloves meet all ASTM D3577-98, requirements for sterility, freedom from holes, physical properties, and physical dimensions."
    21 CFR 800.20 Requirements: Meets requirements for freedom from pinholes."The gloves meet the requirements of 21 CFR 800.20 for freedom from pinholes."
    Non-Irritating and Non-Sensitizing:"The gloves have been tested and have been shown to be non-irritating and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods."
    Powder-Free (ASTM D6124-97):"The gloves have been tested per ASTM D6124-97, and are labeled as powder free."

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

    The document does not explicitly state the sample size used for the test set in the summary provided.
    The data provenance is also not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of product testing for regulatory clearance, it would typically be prospective testing conducted by the manufacturer or a contracted lab.

    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 testing appears to be based on standardized ASTM and CFR requirements, which are objective measurements rather than expert-derived ground truth.

    4. Adjudication Method for the Test Set

    This information is not applicable as the evaluation is based on objective, standardized tests, not subjective interpretations requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A MRMC comparative effectiveness study was not done. The document describes testing of a physical device against established standards, not an AI system or human reader performance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    This is not applicable. The device is a physical product (surgical gloves), not an algorithm or AI.

    7. Type of Ground Truth Used

    The ground truth used is based on objective, standardized measurements and requirements as defined by:

    • ASTM D3577-98 (for sterility, freedom from holes, physical properties, and physical dimensions)
    • 21 CFR 800.20 (for freedom from pinholes)
    • Internationally recognized test methods (for non-irritation and non-sensitization)
    • ASTM D6124-97 (for powder-free status)

    8. Sample Size for the Training Set

    This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

    This is not applicable as there is no training set for this device.

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