Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K233068
    Device Name
    Disposable Surgical Gown
    Manufacturer
    Nanning TECBOD Biological Technology Co.,Ltd.
    Date Cleared
    2024-03-29

    (185 days)

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

    Nanning TECBOD Biological Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Surgical Gowns are 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. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile.
    Device Description
    Disposable Surgical Gown
    Ask a Question
    K Number
    K223467
    Device Name
    Disposable Isolation Gown
    Manufacturer
    Nanning TECBOD Biological Technology Co.,Ltd.
    Date Cleared
    2023-02-10

    (85 days)

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

    Nanning TECBOD Biological Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns 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 (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.
    Device Description
    Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic. The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.
    Ask a Question

    Page 1 of 1