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510(k) Data Aggregation

    K Number
    K133075
    Device Name
    Plus Surgical Gowns (EO Sterilized), PMGB-XXX
    Manufacturer
    FOSHAN NANHAI PLUS MEDICAL CO., LTD.
    Date Cleared
    2015-06-24

    (632 days)

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

    Plus Surgical Gowns (EO Sterilized), PMGB-XXX

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

    Surgical Gowns (EO Sterilized) are worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text describes an FDA 510(k) clearance letter for "Plus Surgical Gowns (EO Sterilized), PMGB-XXX". This document details the FDA's determination of substantial equivalence for a medical device (surgical gowns) based on existing regulations and predicate devices.

    This document does not contain any information about an AI/ML device, its acceptance criteria, or a study proving its performance. It pertains to traditional medical device clearance. Therefore, I cannot extract the requested information regarding AI device performance, sample sizes, expert qualifications, adjudication methods, or MRMC studies from this text.

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