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510(k) Data Aggregation

    K Number
    K251860

    Validate with FDA (Live)

    Device Name
    Copioumed AAMI 3 Surgical Gown
    Manufacturer
    Copioumed International, Inc.
    Date Cleared
    2026-02-26

    (254 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K170762
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Copioumed AAMI 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. The gown is single-use, disposable, and provided sterile, and is classified as AAMI Level 3.

    Device Description

    Copioumed AAMI 3 Surgical Gown provides protection with the materials of SMS. Copioumed AAMI 3 Surgical Gown has comfort and breathability and for a better fit on the user. The neck design of Copioumed Surgical Gown is adjustable and closes with a Velcro. Copioumed Surgical Gown is available in several sizes and lengths with two models (standard performance and high standard).

    AI/ML Overview

    N/A

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