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510(k) Data Aggregation

    K Number
    K213001
    Device Name
    Procedure Mask, Surgical Mask
    Date Cleared
    2022-05-11

    (233 days)

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

    A Plus International, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.
    Device Description
    Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.
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    K Number
    K102861
    Device Name
    SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
    Date Cleared
    2011-01-13

    (105 days)

    Product Code
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    A PLUS INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations. The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization. The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
    Device Description
    SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.
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    K Number
    K093169
    Device Name
    SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
    Date Cleared
    2009-11-12

    (36 days)

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

    A PLUS INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SurgiPlus Surgical Gowns are single use article of surgical apparel intended to be worn by operating room personnel during surgical and other medical procedures to protect both the medical personnel and patients from transfer of blood, body fluids, and particulate materials.
    Device Description
    SurgiPlus Surgical Gowns are single use article of surgical apparel.
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    K Number
    K031353
    Device Name
    SOLUTION FACE MASKS
    Date Cleared
    2003-06-19

    (51 days)

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

    A PLUS INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The A Plus International, Inc. Solution Face Masks are designed as surgical apparel medical devices that are intended to fully cover the nose and mouth for infection control, and to be worn (for example) by operating room personnel during surgical procedures, so as to protect both the surgical patient as well as operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Solution Face Masks may be used as isolation masks, procedure masks, or dental face masks, but not as combination surgical and respirator masks. Solution Face Masks are intended as single use disposable devices and not intended for reuse of any kind.
    Device Description
    Not Found
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