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510(k) Data Aggregation

    K Number
    K232598
    Device Name
    Unscented Menstrual Tampon
    Manufacturer
    Unibeauty (Hubei) Technology Co.,Ltd.
    Date Cleared
    2023-12-15

    (109 days)

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

    Unibeauty (Hubei) Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
    Device Description
    The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.
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