Device Description
Hyalo GYN Vaginal Moisturizing Suppositories are non-sterile, glyceride-based personal lubricants. The subject lubricant is intended to moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. The Hyalo GYN Vaginal Moisturizing Suppositories are provided in peel-to-open pre-cut strips, in an outer cardboard box with a package insert.
Indications for Use
Hyalo GYN Vaginal Moisturizing Suppositories are personal lubricants for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
Hyalo GYN Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Principle of Operation / Technology
Hyalo GYN Vaginal Moisturizing Suppositories are personal lubricants for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication.
510(k) Number:K191052
Device Name: HyaloGYN Vaginal Moisturizing Suppositorie
Manufacturer:FIDIA FARMACEUTICI SPA
Device Name: HyaloGYN Vaginal Moisturizing Suppositorie
Classification Name:LUBRICANT, PERSONAL
Proprietary Name:Hyalo GYN Vaginal Moisturizing Suppositories
Classification Name:LUBRICANT, PERSONAL
Product Code:NUC
Device Class:2
Regulation Number:884.5300
Medical Specialty:Obstetrics/Gynecology
Registered Establishment Name:FIDIA FARMACEUTICI SPA
Registered Establishment Number:9610200
Premarket Submission Number:K191052
Owner/Operator:Fidia Farmaceutici SPA
Owner/Operator Number:9027294
Establishment Operations:Specification Developer