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510(k) Data Aggregation

    K Number
    K220665
    Device Name
    Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
    Date Cleared
    2022-06-03

    (88 days)

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

    Excellent Medical Technology Group Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical Gown, Blue, Sterile and Surgical Gown, Blue, Non-Sterile intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EiO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1. The Surgical Gowns meet the Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.
    Device Description
    Not Found
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