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510(k) Data Aggregation

    K Number
    K242937
    Device Name
    Dream Medi Sterile Surgical Gown (SurgicalGownUL)
    Manufacturer
    DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)
    Date Cleared
    2025-05-05

    (222 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dream Medi Sterile Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
    Device Description
    Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection. The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL). SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene. The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.
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