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510(k) Data Aggregation
K Number
K222567Device Name
Playground For All Love Sesh
Manufacturer
Date Cleared
2023-01-30
(159 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Playground For All
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Playground For All Love Sesh 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
Playground For All Love Sesh is a non-sterile, unscented, water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate. Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.
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