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510(k) Data Aggregation

    K Number
    K023910
    Device Name
    STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
    Manufacturer
    SANREA HEALTHCARE PRIVATE LIMITED
    Date Cleared
    2003-02-11

    (78 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

    Device Description

    POWDERFREE STERILE LATEX EXAMINATION GLOVES

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for Powder-free Sterile Latex Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    Crucially, this document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically requested for AI/software device submissions.

    The letter confirms general compliance with regulations applicable to Class I devices. The "Indications for Use" section simply defines what an examination glove is and its purpose, rather than establishing performance metrics.

    Therefore, I cannot provide the requested information based on the provided text. The document is about regulatory clearance, not performance study results.

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