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510(k) Data Aggregation

    K Number
    K101468
    Device Name
    3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
    Manufacturer
    Date Cleared
    2011-04-14

    (322 days)

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

    3M COMPANY CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification. The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. * *To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow. These gowns are for single use.
    Device Description
    The 3M surgical gowns are sterile, disposable and intended for single use. They come in a variety of sizes (M, L, XL and XXL). Their construction includes a blue nonwoven fabric consisting of either a SMMS or Spunlace. Those gowns that are labeled reinforce include extra reinforced material sheets integrated into parts of the gown within the front panel and on both sleeves from the cuff to the elbow. The gowns include a specific AAMI Liquid Barrier Performance and Classification (i.e. 2 or 4) Level. All gowns are easy to don and include a hook and loop to close the neck and ties for closing the back of the gown. They include functional cuffs constructed of a white knitted material.
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