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510(k) Data Aggregation

    K Number
    K243421
    Device Name
    Lelo Hex Lubricated Natural Rubber Latex Condom
    Manufacturer
    Lelo Inc.
    Date Cleared
    2025-03-07

    (123 days)

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

    Lelo Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm. Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
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    K Number
    K162511
    Device Name
    LELO RESPECT HEX Natural Rubber Latex Condom
    Manufacturer
    LELO INC.
    Date Cleared
    2017-01-13

    (127 days)

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

    LELO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LELO RESPECT HEX Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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    K Number
    K160644
    Device Name
    Lelo Hex Natural Rubber Latex Condom
    Manufacturer
    LELO Inc.
    Date Cleared
    2016-06-30

    (115 days)

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

    LELO Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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