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510(k) Data Aggregation

    K Number
    K232470
    Device Name
    Polyisoprene Extra Large Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2024-05-09

    (267 days)

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

    Suretex Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).
    Device Description
    The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.
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    K Number
    K231908
    Device Name
    45 Micron Polyisoprene Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2023-10-27

    (120 days)

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

    Suretex Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
    Device Description
    The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
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    K Number
    K232279
    Device Name
    LifeStyles NRL Textured Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2023-10-05

    (66 days)

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

    Suretex Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.
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    K Number
    K221243
    Device Name
    OFNat Lubricant (L15)
    Manufacturer
    Suretex Limited
    Date Cleared
    2022-09-30

    (151 days)

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

    Suretex Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OFNat Lubricant (L15) is a personal lubricant for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum. OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.
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    K Number
    K213921
    Device Name
    Microthin Natural Rubber Latex Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2022-04-28

    (134 days)

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

    Suretex Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microthin Natural Rubber Latex Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Microthin Natural Rubber Latex Condom is a male contraceptive made of natural rubber latex that completely covers the penis with a closely fitted membrane sheath. The condom is provided lubricated with silicone oil. The condom is straight-walled, with a smooth surface and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 170mm ± 10mm, width 52 ± 2mm, and thickness 0.035mm ± 0.005mm. The condom conforms to the recognized standards ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods. The condom has a 5-year shelf-life.
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