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510(k) Data Aggregation

    K Number
    K230049
    Device Name
    SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
    Manufacturer
    TTK Healthcare Limited
    Date Cleared
    2023-09-07

    (244 days)

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

    TTK Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The subject SKORE Male Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane and used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. The subject device in this submission consists of SKORE Smooth, Dotted &Thin Condoms, SKORE Bulbous Condoms, and SKORE Benzocaine Condoms.
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    K Number
    K213547
    Device Name
    SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
    Manufacturer
    TTK Healthcare Limited
    Date Cleared
    2021-12-23

    (45 days)

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

    TTK Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Tangerine Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    SKORE Smooth Condoms - SKORE Colors & Flavors and SKORE Smooth Condoms -SKORE Vanilla are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject device is an update to the SKORE (Colors & Flavors) condoms cleared under K202403 to modify the texture (dotted to smooth), use a different yellow pigment, and introduce a new flavor (vanilla). The subject devices in this submission consists of - SKORE Colors & Flavors SKORE Strawberry; SKORE Banana; SKORE . Chocolate; SKORE Tangerine; These condoms are parallel straight walled, teat ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject devices include the colors, Red; Yellow; Brown; Orange; and flavors Strawberry, Banana, Chocolate and Tangerine. - SKORE Flavors SKORE Vanilla; This condom is parallel straight walled, teat ● ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject device include the flavor Vanilla and has a natural (no pigment) color.
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    K Number
    K202403
    Device Name
    SKORE (Colors & Flavors), SKORE (Colors)
    Manufacturer
    TTK Healthcare Limited
    Date Cleared
    2021-04-15

    (237 days)

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

    TTK Healthcare Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKORE Red, SKORE Yellow, SKORE Brown, SKORE Orange & SKORE Strawberry, SKORE Cherry, SKORE Banana, SKORE Pinacolada, SKORE Tangerine, SKORE Chocolate and SKORE Cool Mint, Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    SKORE Condoms (Colors & Flavors) and SKORE Condoms (Flavors) are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject devices in this submission consists of - SKORE Colors SKORE Red; SKORE Yellow; SKORE Brown; SKORE Orange. . These condoms are parallel straight walled, teat ended, with a smooth surface Natural Rubber Latex Condoms in the colors Red. Yellow, Brown, and Orange; having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.065 ±0.010 mm, per ASTM D3492:2016 and ISO 4074:2015. - SKORE Colors & Flavors SKORE Strawberry; SKORE Cherry; SKORE . Banana; SKORE Pinacolada; SKORE Tangerine; SKORE Chocolate; SKORE Cool Mint. These condoms are parallel straight walled, teat ended, with a dotted surface having a length of 190 ± 10 mm, width of 53 ± 2 mm and a thickness of 0.065 ± 0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
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