Search Results
Found 1 results
510(k) Data Aggregation
K Number
K242958Device Name
Joylux Intimacy Gel (PG3100)
Manufacturer
Joylux, Inc
Date Cleared
2025-03-20
(176 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Joylux, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
Ask a Question
Page 1 of 1