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510(k) Data Aggregation

    K Number
    K120245
    Device Name
    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
    Manufacturer
    PLAYTEX, INC.
    Date Cleared
    2012-06-21

    (146 days)

    Product Code
    HIL,HEB
    Regulation Number
    884.5460
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K073662,K070745,K072376
    Why did this record match?
    Device Name :

    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

    Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

    Absorbency Ranges:

    Absorbs menstrual flow

    Device Description

    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

    AI/ML Overview

    The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Absorbency Range per 21 CFR §801.430(f)(2))Reported Device Performance (Absorbency Grams)
    Slender Light
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