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510(k) Data Aggregation

    K Number
    K070428
    Device Name
    MEDICOM SELF-SEALING STERILIZATION POUCH
    Manufacturer
    A.R. MEDICOM, INC.
    Date Cleared
    2007-07-17

    (154 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R. MEDICOM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
    Device Description
    The pouches are manufactured from a medical grade paper that is thermally sealed to a laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The pouches contain external indicators used to indicate the pouches were processed via steam or EO sterilization.
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    K Number
    K051291
    Device Name
    NON-STERILE SURGICAL MASK
    Manufacturer
    A.R. MEDICOM, INC.
    Date Cleared
    2005-09-20

    (125 days)

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

    A.R. MEDICOM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
    Device Description
    The new surgical masks are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% medical grade tissue paper or 100% SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices.
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