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510(k) Data Aggregation

    K Number
    K971076
    Device Name
    PRIMED SHOE COVERS, PRIMED HEAD COVERS
    Manufacturer
    PRIMELINE MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-13

    (295 days)

    Product Code
    FXP
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIMED SHOE COVERS, PRIMED HEAD COVERS

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

    Surgical Apparels, shoe and head covers, are worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    Device Description

    PrimeLine Medical Products Inc., priMED brand Head and Shoe Covers

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "Primed Shoe Covers, Primed Head Covers" and an associated "Statement of Indications for Use". This document does not describe a study that involves acceptance criteria for device performance, nor does it contain information about AI-powered devices or diagnostic algorithms.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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