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510(k) Data Aggregation

    K Number
    K202310
    Device Name
    Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
    Manufacturer
    Wildcat PPE, LLC
    Date Cleared
    2021-01-29

    (168 days)

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

    Wildcat PPE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSV/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSVAAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.
    Device Description
    The Wildcat PE Surgical Isolation Gown Full Back is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code FYC. Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided nonsterile. Wildcat PE Surgical Isolation Gown Full Back is offered in one color (blue) and one universal size. Each model is constructed of Linear Low- Density Polyethylene and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3.
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