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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?
    Applicant Name (Manufacturer) :

    Brazen Goods Inc. dba Lorals

    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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