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    K Number
    K132208
    Device Name
    ONTEX AND OTHERS PROPRIETARY NAMES
    Manufacturer
    ONTEX BVBA
    Date Cleared
    2014-04-10

    (268 days)

    Product Code
    HIL, DEV
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
    Device Description
    The Scented Tampons are: 1) Scented Digital 2) Scented Plastic Applicator (full size (long) and compact) They are scented versions because of the presence of a fragrance. Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge. These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super (9-12g), and super plus (12-15g). These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is in polyester and cotton. Applicators are in polyethylene. Roll-tampon: sheet of absorbent material is rolled and pressed. W-tampon: sheet of absorbent material is folded and pressed from two sides simultaneously. Long applicator: inner tube and outer tube are ready to be used immediately. Compact applicator: inner tube and outer tube are slided into each other telescopically. The inner tube needs to be retracted before usage. Except for the perfume, the materials used in these tampons are similar to materials of legally marketed tampons.
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    K Number
    K132819
    Device Name
    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
    Manufacturer
    PLAYTEX MANUFACTURING INC.
    Date Cleared
    2013-10-09

    (30 days)

    Product Code
    HIL, HEB
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid. Absorbency Ranges: Absorbs menstrual flow < 6 grams (Light) Absorbs menstrual flow 6-9 grams (Regular) Absorbs menstrual flow 9-12 grams (Super) Absorbs menstrual flow 12-15 grams (Super Plus)
    Device Description
    Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
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    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
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 < 6 grams (Slender Light) Absorbs menstrual flow 6-9 grams (Slender Regular, Regular) Absorbs menstrual flow 9-12 grams (Super) Absorbs menstrual flow 12-15 grams (Super Plus) Absorbs menstrual flow 15-18 grams (Ultra)
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K111684
    Device Name
    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
    Manufacturer
    PLAYTEX MANUFACTURING INC.
    Date Cleared
    2012-02-03

    (233 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K081555
    Device Name
    TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
    Manufacturer
    PROCTER & GAMBLE CO.
    Date Cleared
    2008-06-27

    (24 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.
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    K Number
    K073662
    Device Name
    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2008-01-17

    (22 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K072376
    Device Name
    PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2007-12-12

    (110 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K070745
    Device Name
    MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2007-04-13

    (25 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K060981
    Device Name
    PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2006-05-09

    (29 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
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    K Number
    K051446
    Device Name
    FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC INC.
    Date Cleared
    2005-07-14

    (42 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Product Code :

    HIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.
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