Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213832
    Device Name
    AAMI3 Isolation Gown
    Date Cleared
    2022-05-16

    (158 days)

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

    Hubei Xinxin Non-woven Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Isolation Gown, Model 4005 and 4022, is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not in the operating room. In addition, the Isolation Gown, Model 4005 and 4022 meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gown, Model 4005 and 4022, is a single use, disposable medical device provided non-sterile. Protective Gown, Model 4021, is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. The Protective Gown, Model 4021, is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1