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510(k) Data Aggregation

    K Number
    K190306
    Device Name
    AMD Ritmed AssureWear VersaGown
    Manufacturer
    AMD Medicom Inc.
    Date Cleared
    2020-01-17

    (339 days)

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

    AMD Medicom Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and Xlarge sizes.
    Device Description
    AMD Ritmed AssureWear™ VersaGown isolation gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown ger ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, disposable medical device provided nonsterile and non-intended for use in operating rooms and is constructed of polypropylene Spunbond--Meltblown-Spunbond Nonwovens (SMS), non-woven and coated with polyethylene. The isolation gown consists of one critical zone throughout the entire gown including the seams and belt attachments but excluding cuffs, hems and bindings.
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