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510(k) Data Aggregation
K Number
K190323Device Name
Aloe Glide Lubricant
Manufacturer
Date Cleared
2019-09-25
(224 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Desert Harvest, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aloe Glide 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
Aloe Glide Lubricant is a personal lubricant that is non-sterile, waterbased, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, xanthan gum, licorice and marshmallow extract, aloe barbadensis leaf extract, potassium sorbate, citric acid, and natapres. Aloe Glide is packaged in 2, 4, and 8 fl. oz bottles composed of polyethylene terephthalate (PET). Aloe Glide lubricant is a personal lubricant for over-the-counter (OTC) use.
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