Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K112136
    Device Name
    TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
    Date Cleared
    2011-09-29

    (65 days)

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

    KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable sterile drapes are intended for use for : - patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures. - cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.
    Device Description
    The document lists the following disposable surgical drape types and model numbers included in the submission: | MATERIAL | DRAPE STYLE | STERILE | DRAPE TYPE | MODEL # | |----------|-------------------|-------------|------------|-----------------| | SMS | Non<br>Reinforced | Sterile | Top | JHSAD 150-240E | | | | | Bottom | JHSAD 180-175E | | | | Non Sterile | Top | JHSAD 150-240NS | | | | | Bottom | JHSAD 180-175NS |
    Ask a Question

    Ask a specific question about this device

    K Number
    K111067
    Device Name
    JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
    Date Cleared
    2011-08-02

    (106 days)

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

    KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material. Gowns are provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1