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510(k) Data Aggregation

    K Number
    K182142
    Device Name
    FEMME Applicator Tampon
    Date Cleared
    2019-08-28

    (386 days)

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

    Jiangsu YOAI Technology co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FEMME Applicator Tampon is an unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the tampon correctly into the vagina.
    Device Description
    The FEMME Applicator Tampon is an unscented, menstrual tampon. The tampon is comprised of an absorbent viscose pledget, an overwrap, a removal string, and an applicator. The applicator contains 3 parts: a barrel, grip, and plunger. The tampon was designed as a compact tampon with a mushroom-shaped tip. The pledget is of the traditional cylindrical bullet-like shape and is covered with a thin layer of overwrap. The applicator has a standard rounded and smooth tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit container for retail sale. There are 3 specifications of tampon with different absorbencies: Regular, Super and Super plus. Each absorbency specification has a different color removal string and applicator.
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