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510(k) Data Aggregation

    K Number
    K141324
    Device Name
    HONGYU DISPOSABLE SURGICAL DRAPES
    Manufacturer
    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
    Date Cleared
    2015-04-14

    (329 days)

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

    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only. This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities. Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.
    Device Description
    HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only. This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities. HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape. The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.
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    K Number
    K120192
    Device Name
    DISPOSABLE SURGICAL GOWNS
    Manufacturer
    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
    Date Cleared
    2012-10-16

    (267 days)

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

    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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 could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only.
    Device Description
    Disposable Surgical Gowns 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. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description.
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