Search Results
Found 1 results
510(k) Data Aggregation
K Number
K202017Device Name
Passion Natural Water Based Lubricant
Manufacturer
Date Cleared
2021-01-08
(171 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
XR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Passion Natural Water Based 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
Device Description
The Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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 polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.
Ask a Question
Ask a specific question about this device
Page 1 of 1