Search Filters

Search Results

Found 20 results

510(k) Data Aggregation

    K Number
    K243967
    Device Name
    ONE Nitrile Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2025-04-08

    (106 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
    Ask a Question
    K Number
    K241617
    Device Name
    Durex Polyisoprene Condom
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2025-02-28

    (268 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Polyisoprene Condom is used for contraception and for prophylactic purposes (to help regnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Not Found
    Ask a Question
    K Number
    K240379
    Device Name
    TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2024-10-08

    (244 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).
    Ask a Question
    K Number
    K240896
    Device Name
    ONE Nitrile Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2024-08-23

    (144 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
    Ask a Question
    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?
    Product Code :

    MOL

    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.
    Ask a Question
    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?
    Product Code :

    MOL

    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.
    Ask a Question
    K Number
    K203541
    Device Name
    Okamoto 002 Lubricated Polyurethane Male Condom
    Manufacturer
    Okamoto U.S.A. Inc.
    Date Cleared
    2022-02-25

    (449 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Okamoto 002 Lubricated Polyurethane Male 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
    This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.
    Ask a Question
    K Number
    K182438
    Device Name
    Synthetic Polyisoprene Lubricated Male Condom - 5 senses
    Manufacturer
    Sxwell Usa LLC
    Date Cleared
    2018-12-06

    (90 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
    Device Description
    The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming. 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 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
    Ask a Question
    K Number
    K171172
    Device Name
    Skyn Original Polyisoprene Lubricated Male Condom - Flavored
    Manufacturer
    Ansell Healthcare Products LLC.
    Date Cleared
    2017-08-02

    (103 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
    Device Description
    The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. 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 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
    Ask a Question
    K Number
    K171639
    Device Name
    Trojan Supra Lubricated Polyurethane Male Condom
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2017-08-01

    (60 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
    Device Description
    The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
    Ask a Question

    Page 1 of 2