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510(k) Data Aggregation

    K Number
    K252613

    Validate with FDA (Live)

    Device Name
    Unscented menstrual three-piece applicator tampon
    Manufacturer
    Unibeauty (Hubei) Technology Co.,Ltd.
    Date Cleared
    2025-09-19

    (31 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K251033,K232598
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The unscented menstrual three-piece applicator tampons are inserted into the vagina to absorb menstrual discharge.

    Device Description

    The unscented menstrual three-piece applicator tampon consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator. The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

    According to different composition materials, the unscented menstrual three-piece applicator tampon of this submission are divided into 4 categories (Cotton tampon with three piece applicator, Organic cotton tampon with three piece applicator, Viscose tampon with three piece applicator, Viscose +Cotton tampon with three piece applicator).

    The Tampon are provided in 4 absorbency: Light (L) (absorbency ≤6g), Regular (R) (6-9g), Super (S) (9-12g) and Super Plus (SP) (12-15g).

    Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

    AI/ML Overview

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