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510(k) Data Aggregation
K Number
K212928Device Name
Lorals
Manufacturer
Brazen Goods Inc. dba Lorals
Date Cleared
2022-04-22
(220 days)
Product Code
MSC, DAT
Regulation Number
884.5300Why 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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