Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K192669
    Device Name
    Extremely Thin 003, ZERO ZERO THREE
    Manufacturer
    Okamoto U.S.A., Inc.
    Date Cleared
    2020-07-24

    (303 days)

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

    Okamoto U.S.A., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
    Device Description
    The device is a condom that is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, teat-ended, silicone-lubricated condom with nominal length 180 ± 2mm, nominal width 53.5 ± 2mm, and nominal thickness of 0.04 mm. This condom conforms to the recognized standards ASTM D3492-16 and ISO 4074:2015.
    Ask a Question
    K Number
    K141256
    Device Name
    OKAMOTO STUDDED CONDOM
    Manufacturer
    OKAMOTO U.S.A., INC.
    Date Cleared
    2014-07-23

    (70 days)

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

    OKAMOTO U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008. The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039).
    Ask a Question
    K Number
    K140379
    Device Name
    MEGA BIG BOY CONDOM
    Manufacturer
    OKAMOTO U.S.A., INC.
    Date Cleared
    2014-07-01

    (137 days)

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

    OKAMOTO U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/ADS and the transmission of sexually transmitted infections).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is smooth surface, flared at the closed end with reservoir tip, silicone lubricated condom with nominal length 200 mm, nominal flat width 57 mm, and nominal thickness of 0.065 mm. The air burst pressure is > 1 kPa and air burst volume is > 19 dm3. It is lubricated with silicone (viscosity 350 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008.
    Ask a Question
    K Number
    K090259
    Device Name
    OKAMOTO ULTRA THIN
    Manufacturer
    OKAMOTO U.S.A., INC.
    Date Cleared
    2009-03-31

    (57 days)

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

    OKAMOTO U.S.A., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.
    Ask a Question

    Page 1 of 1