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510(k) Data Aggregation

    K Number
    K222529
    Device Name
    Surgical Face Mask
    Manufacturer
    Xiantao Rayxin Medical Products Co., Ltd.
    Date Cleared
    2022-11-14

    (84 days)

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

    Xiantao Rayxin Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The Surgical Face Mask is single use, three-layer, flat-pleated style with ear loops/tie-coverall and nose piece. The Surgical Face Mask is 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 ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of polyester and spandex, the ties are made of spun-bond polypropylene. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and aluminum. The Surgical Face Mask will be provided in blue. The Surgical Face Mask is sold as non-sterile and are intended to be single use, disposable devices.
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    K Number
    K173847
    Device Name
    Disposable Ultra Reinforced Surgical Gown
    Manufacturer
    Xiantao Rayxin Medical Products Co., ltd.
    Date Cleared
    2019-01-16

    (393 days)

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

    Xiantao Rayxin Medical Products Co., ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Ultra Reinforced Surgical Gown is 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. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile
    Device Description
    The Disposable Ultra Reinforced Surgical Gown is reinforced surgical gown, which is comprised of a single layer blue non-woven fabric SMS, and an additional layer of SMS in critical zones of sleeve and front chest. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
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    K Number
    K153496
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2016-06-15

    (191 days)

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

    XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch. 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, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene. The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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