LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053102
    Device Name
    BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2006-03-10

    (126 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE

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

    A powder-free sterile surgeon's glove is a disposable device made of Non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    Non-latex sterile powder-free surgeon's glove

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. This document is a 510(k) clearance letter from the FDA for a non-latex sterile powder-free surgeon's glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not include details about:

    • Acceptance criteria and reported device performance related to a study.
    • Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
    • Any information regarding a multi-reader, multi-case study or standalone algorithm performance.
    • Training set details for an algorithm.

    This document is a regulatory approval, not a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1