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510(k) Data Aggregation

    K Number
    K071827
    Device Name
    ALWAYS MENSTRUAL PADS
    Date Cleared
    2007-09-20

    (79 days)

    Product Code
    Regulation Number
    884.5435
    Why did this record match?
    Product Code :

    HHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
    Device Description
    The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
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    K Number
    K012629
    Device Name
    ALWAYS DUETS
    Date Cleared
    2001-10-05

    (53 days)

    Product Code
    Regulation Number
    884.5435
    Why did this record match?
    Product Code :

    HHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways: - Alone for light and medium (menstrual) flow . - In combination with tampons or pads for extra protection during heavy . (menstrual) flow - Alone for vaginal discharge or slight urine loss associated with laughs, . coughs, and sneezes. The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways: - For menstrual flow or other vaginal discharge .
    Device Description
    The interlabial pad device has 3 primary components: - 1. The permeable topsheet allows fluid to pass through into the core. - 2. The absorbent core acquires and stores the fluid. - 3. The impermeable backsheet prevents fluid transfer beyond the core. The absorbent core is held in place between the topsheet and backsheet, which are bonded at the perimeter to form an ellipse-shaped trilaminate structure. An attached tab glued onto the backsheet extends from the back of the device as an aid for application and removal. The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale.
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    K Number
    K003843
    Device Name
    ENVIVE MINIFORMS
    Date Cleared
    2001-02-08

    (58 days)

    Product Code
    Regulation Number
    884.5435
    Why did this record match?
    Product Code :

    HHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993870
    Device Name
    UNSCENTED INTERLABIAL MENSTRUAL PAD
    Date Cleared
    2000-01-18

    (64 days)

    Product Code
    Regulation Number
    884.5435
    Why did this record match?
    Product Code :

    HHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Unscented Interiabial Menstrual Pad can be wom any time of the day or night in the following ways: Alone for light and medium (menstrual) flow; In combination with tampons or pads for extra protection during heavy (menstrual) flow; Alone for vaginal discharge or slight urine loss associated with laughs, coughs, and sneezes.
    Device Description
    The device has 3 primary components: 1. The permeable topsheet allows fluid to pass through into the core. 2. The absorbent core acquires and stores the fluid. 3. The impermeable backsheet prevents fluid transfer beyond the core. The absorbent core is held in place between the topsheet and backshoet, which are bonded at the perimeter to form an ovoid trilaminate structure. A tab formed from the backsheet extends from the back of the device as an aid for application and removal, The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale,
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    K Number
    K980395
    Device Name
    GLADRAGS COTTON MENSTRUAL PAD
    Manufacturer
    Date Cleared
    1998-04-16

    (73 days)

    Product Code
    Regulation Number
    884.5435
    Why did this record match?
    Product Code :

    HHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.
    Device Description
    GladRags Cotton Menstrual Pads
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