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510(k) Data Aggregation

    K Number
    K212928
    Device Name
    Lorals
    Manufacturer
    Brazen Goods Inc. dba Lorals
    Date Cleared
    2022-04-22

    (220 days)

    Product Code
    MSC, DAT
    Regulation Number
    884.5300
    Why did this record match?
    Product Code :

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lorals are used as a barrier when engaging in oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
    Device Description
    Lorals are wearable, single-use, natural rubber latex oral dams that are placed over the vagina and/or anus during oral sexual contact. Lorals are designed similar to underwear, with a region that covers the genital region and a waistband to keep the dam in place, all made from natural rubber latex. The dams are available in two designs, Shortie and Bikini, which provide the same coverage of the genital region, but have different waistband heights, based on user preference. Each design is available in 3 different gusset sizes. The dams are scented with vanilla fragrance and are provided in black only.
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    K Number
    K212037
    Device Name
    SancDam Latex Oral Dam
    Manufacturer
    Sanctuary Health Sdn. Bhd.
    Date Cleared
    2022-03-28

    (271 days)

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

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
    Device Description
    The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.
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    K Number
    K203727
    Device Name
    Harmony Latex Dam, Harmony Non-Latex Dam
    Manufacturer
    Pamco Distributing Inc.
    Date Cleared
    2021-08-05

    (227 days)

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

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/ anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.
    Device Description
    The Harmony® Latex and Harmony® Polyisoprene Dams are rectangular shaped non-porous, intact polymer film that are placed over the vagina or anus during oral sexual contact. The dam provides coverage to the external female genitalia or to the anal acts as a physical barrier to infectious agents responsible for the transmission of sexually transmitted infections (STIs). Both Harmony® Latex and Harmony® Polyisoprene Dams are 152.4 mm (6") x 254 mm (10") and 0.12 mm thick. The Harmony® Latex Dam contains natural polyisoprene rubber and the Harmon® Polyisoprene Dam contains synthetic polyisoprene rubber. The dams are slightly scented with vanilla fragrance and are provided in natural color.
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    K Number
    K091769
    Device Name
    TRUST DAM
    Manufacturer
    LINE ONE LABORATORIES, INC.
    Date Cleared
    2010-02-05

    (234 days)

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

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.
    Device Description
    This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material. The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830). The condoms will be offered in the following Colors and Flavors: 1. Yellow Banana 2. Red Strawberry 3. Green Mint
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    K Number
    K990067
    Device Name
    SHEER GLYDE DAMS
    Manufacturer
    LOUISE C. MYERS
    Date Cleared
    1999-02-19

    (42 days)

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

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sheer Glyde Dams™ are a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]). Sheer Glyde Dams™, when properly used, may help reduce the risk of catching or spreading many Sexually Transmitted Diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes, and AIDS; however, they cannot eliminate the risk. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Sheer Glyde Dams™ should be applied each and every time before any such contact occurs. WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE. WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION, STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.
    Device Description
    Sheer Glyde Dams™ are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Sheer Glyde Dams™ is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (+ 0.0006 millimeters.) Sheer Glyde Dams™ are designed to be used while performing either cunnilingus or anilingus. Qualification testing (biocompatibility, tensile strength/elongation, and virus) was previously performed to satisfactorily conclude that Sheer Glyde Dams™ operate as intended, when used properly. Finally, Sheer Glyde Dams™ are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.
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    K Number
    K970577
    Device Name
    GLYDE DAM LOLLYES
    Manufacturer
    GLYDE USA, INC.
    Date Cleared
    1998-01-08

    (328 days)

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

    MSC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glyde Dam Lollyes Mare a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex. Glyde Dam Lollyes™, when properly used, may help reduce the risk of catching or spreading many sexually transmitted diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes and AIDS. However, they cannot eliminate the risk. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Glyde Dam Lollyes™ should be applied each and every time before any such contact occurs. WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE. WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION. STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.
    Device Description
    Glyde Dam Lollyes are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Glyde Dam Lollyes is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (± 0.0006 millimeters.) Glyde Dam Lollyes are designed to be used while performing cunnilingus. Qualification testing (biocompatibility, tensile strength/elongation, and virus) has been performed to satisfactorily conclude that Glyde Dam Lollyes operate as intended, when used properly. Finally, Glyde Dam Lollyes are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.
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