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510(k) Data Aggregation

    K Number
    K210215
    Device Name
    Surgical Gowns
    Date Cleared
    2021-07-07

    (161 days)

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

    Jiangsu Province Jianerkang Medical Dressing Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical gown are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made of soft, air permeable SMS non-woven fabric. The Jianerkang Surgical Gown is made of a laminate with adhesive taped seams and have a hook and loop closure at the back of the neck and a waist tie feature to secure the gown to the body of the user. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. The entire gown including the gown sleeves are made of the same material and utilize the same manufacturing processes.
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    K Number
    K202061
    Device Name
    Medical Face mask
    Date Cleared
    2020-12-23

    (149 days)

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

    Jiangsu Province Jianerkang Medical Dressing Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
    Device Description
    The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire. It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled. The product is level 1 according to ASTM F2100-19.
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