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510(k) Data Aggregation

    K Number
    K062479
    Device Name
    JOYKEY SURGICAL GOWNS (STERILE)
    Date Cleared
    2007-03-14

    (202 days)

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

    JOYKEY INDUSTRYIAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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
    JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
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    K Number
    K062480
    Device Name
    JOYKEY SURGICAL DRAPES (STERILE)
    Date Cleared
    2007-03-05

    (193 days)

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

    JOYKEY INDUSTRYIAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
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