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510(k) Data Aggregation

    K Number
    K241064
    Device Name
    Unscented Tampon
    Manufacturer
    Shandong Intco Hygiene Products Co., Ltd.
    Date Cleared
    2025-01-10

    (267 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Intco Hygiene Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unscented Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
    Device Description
    The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (6~9g), super (9~12g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.
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