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510(k) Data Aggregation

    K Number
    K022156
    Device Name
    LATEX ULTRASONIC PROBE COVER
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2003-09-11

    (436 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as vagina to facilitate cleaning and sanitization of the probe.
    Device Description
    SURE ™ Latex Ultrasonic Probe Cover
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    K Number
    K023333
    Device Name
    MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2003-06-23

    (259 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    [No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide.
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    K Number
    K021875
    Device Name
    MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2002-09-05

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases )
    Device Description
    Latex Condom with Dotted/Ribbed Surface and Contour-walled Shape
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    K Number
    K020272
    Device Name
    MALE LATEX CONDOM WITH RIBBED SURFACE
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2002-04-26

    (88 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Male Latex Condom with Ribbed Surface (No Particular Brand Name)
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    K Number
    K002571
    Device Name
    MULITPLE MALE LATX CONDOM
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-11-16

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001377
    Device Name
    SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-06-08

    (38 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001221
    Device Name
    MALE LATEX COMDOM WITH DOTTED SURFACE
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-05-19

    (32 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994311
    Device Name
    MALE LATEX CONDOM WITH VANILLA FLAVOR
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-03-21

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Male Natural Rubber Latex Condom with Vanilla Flavor, 56 mm width
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    K Number
    K994312
    Device Name
    MALE LATEX CONDOM 56MM
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-03-21

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No varticular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Male Natural Rubber Latex Condom [No particular brand name]
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    K Number
    K982380
    Device Name
    SURE
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    1999-02-26

    (233 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLEASURE LATEX PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used in accordance with manufacturer's instruction, condoms are effective form of contraception. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital warts, gonorthea, hepatitis B and syphilis.
    Device Description
    Not Found
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