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510(k) Data Aggregation

    K Number
    K222480
    Device Name
    Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
    Manufacturer
    Foshan Nanhai Plus Medical Co., Ltd.
    Date Cleared
    2022-11-14

    (89 days)

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

    Foshan Nanhai Plus Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
    Device Description
    Not Found
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN NANHAI PLUS MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K133080
    Device Name
    Plus Surgical Drapes (EO Sterilized), PMDB-XXX
    Manufacturer
    FOSHAN NANHAI PLUS MEDICAL CO., LTD.
    Date Cleared
    2015-06-24

    (632 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN NANHAI PLUS MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    Not Found
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