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510(k) Data Aggregation

    K Number
    K972277
    Device Name
    DIGIFLEX SURGICAL GLOVES
    Manufacturer
    HMS SERVICES, INC.
    Date Cleared
    1997-10-21

    (125 days)

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

    A Surgical 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

    Sterile Surgical Glove ( POWDERE

    AI/ML Overview

    This looks like a 510(k) clearance letter for "Digiflex Surgical Gloves (Powdered)". This document does NOT contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device would.

    The document is purely a regulatory letter stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section simply defines what a surgical glove is generally used for, not specific performance metrics.

    Therefore, I cannot provide the requested information from this document. The questions you've asked are typical for a submission involving diagnostic algorithms or software, not for a physical medical device like surgical gloves.

    To answer your request, I would need a document detailing a clinical study or performance validation for a diagnostic device.

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