LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K993794
    Device Name
    PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
    Manufacturer
    PLAYTIME PRODUCTS, INC.
    Date Cleared
    2000-02-07

    (90 days)

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

    PLAYTIME PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unscented menstrual tampons for absorption of menstrual fluid.
    Device Description
    Unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K981760
    Device Name
    PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
    Manufacturer
    PLAYTIME PRODUCTS, INC.
    Date Cleared
    1998-07-22

    (64 days)

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

    PLAYTIME PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unscented menstrual tampons for absorption of menstrual fluid.
    Device Description
    Unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K964269
    Device Name
    PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
    Manufacturer
    PLAYTIME PRODUCTS, INC.
    Date Cleared
    1996-11-29

    (35 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTIME PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    TSST-I, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #29696 and the predicate device Dioxin Analysis Primary Dermal Irritation in Rabbits Non-Irritating Acute Oral Toxicity in Rats - Non-Toxic Subacute Vaginal Irritation in Rabbits - Non-Irritating Human Repeat Insult Patch Test Non-Irritating and not a Sensitizer Agar Diffusion Study No zones of inhibitation were detected
    Ask a Question
    K Number
    K961456
    Device Name
    PLAYTEX TAMPONS #10296
    Manufacturer
    PLAYTIME PRODUCTS, INC.
    Date Cleared
    1996-06-18

    (63 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTIME PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1