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510(k) Data Aggregation

    K Number
    K233183
    Device Name
    Surgical Gown (40083)
    Manufacturer
    Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
    Date Cleared
    2024-02-01

    (126 days)

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

    Ammex-Weida (Hubei) Health and Safety Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
    Device Description
    The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.
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    K Number
    K211062
    Device Name
    Medical Face Mask
    Manufacturer
    Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
    Date Cleared
    2021-06-08

    (60 days)

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

    Ammex-Weida (Hubei) Health and Safety Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and polyester. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene coated galvanized wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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