BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS

    K Number: K964269 · Decision Nov 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    8
    Review Days
    35

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    Basic Information

    Device Name
    PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
    K Number
    K964269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Playtime Products, Inc.
    Date Received
    October 25, 1996
    Decision Date
    November 29, 1996
    Product Code
    HIL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIL Tampon, Menstrual, Scented, Scented-Deodorized

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.

    ONTEX AND OTHERS PROPRIETARY NAMES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Playtime Products, Inc.

    K Number Device Name
    K993794 PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
    K981760 PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
    K961456 PLAYTEX TAMPONS #10296
    K952394 PLAYTEX TAMPONS #13695
    K950928 ULTIMATES SILK GLIDE TAMPONS
    K923375 PLAYSKOOL SUNGLASSES
    K923374 VARIOUS SUNGLASSES