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510(k) Data Aggregation

    K Number
    K210785
    Device Name
    Disposable Surgical Gowns
    Manufacturer
    Chongqing Litai Fashion Group Limited Company
    Date Cleared
    2021-11-13

    (242 days)

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

    Chongqing Litai Fashion Group Limited Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Surgical 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 Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices: provided non-sterile.
    Device Description
    Surgical Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is SMS compound non-woven fabric. It is a kind of Non- Reinforced surgical isolation gown. Disposable Surgical Isolation Gowns are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Surgical Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations with 6 sizes, S, M, L, XL, XXL, and XXXL.
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