Search Results
Found 1 results
510(k) Data Aggregation
K Number
K191654Device Name
SILICONE Personal Lubricant
Manufacturer
Date Cleared
2020-04-14
(299 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Bath Concept Cosmetics (Dongguan) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
SILICONE Personal Lubricant is a non-sterile, clear and odorless siliconebased personal lubricant for use during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. Its formulation consists of dimethicone and dimethiconol. The product is packed into a 3.38 oz (100 mL) bottle.
Ask a Question
Ask a specific question about this device
Page 1 of 1