Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221137Device Name
Play and Joy Water-Based Lubricant
Manufacturer
Date Cleared
2023-07-11
(448 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
InnoveMed Bio-tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Play and Joy Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane, and polyisoprene condoms.
Device Description
Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.
Ask a Question
Ask a specific question about this device
K Number
K220646Device Name
Play&Joy InvisiLube Lubricant Capsule
Manufacturer
Date Cleared
2023-07-10
(493 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
InnoveMed Bio-tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms
Device Description
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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. Play & Joy InvisiLube Lubricant Capsule is a non-sterile, anhydrous silicone inner component encapsulated with a gelatin shell. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The inner component is composed of a blend of silicone with primary ingredients: Cyclopentasiloxane, Dimethiconol, and Dimethicone. The gelatin shell is composed of gelatin, glycerin, Phatic acid, and water.
Ask a Question
Ask a specific question about this device
Page 1 of 1