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510(k) Data Aggregation
K Number
K221829Device Name
Wet Flavored Personal Lubricants
Manufacturer
Trigg Laboratories, Inc.
Date Cleared
2022-09-23
(92 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Trigg Laboratories, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wet Flavored Personal Lubricants are personal lubricants 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. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Device Description
The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow. The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.
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K Number
K220534Device Name
Wet Essential95 Personal Lubricant
Manufacturer
Trigg Laboratories, Inc.
Date Cleared
2022-07-07
(133 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Trigg Laboratories, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wet Essential95 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
The Wet Essential95 Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.
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K Number
K191480Device Name
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Manufacturer
Trigg Laboratories, Inc. D/B/A Wet International
Date Cleared
2019-10-11
(129 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Trigg Laboratories, Inc. D/B/A Wet International
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a personal lubricant for penile, anal 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
The Wet Water Based Personal Lubricant is a non-sterile, water and silicone blend personal lubricant that provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. The Wet Water Based Personal Lubricant is provided in 3 oz.high density polyethylene terephthalate bottle is fitted with dispensing bottle cap with a disc-top. Wet Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
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K Number
K130012Device Name
WET PLATINUM PERSONAL LUBRICANT
Manufacturer
TRIGG LABORATORIES, INC.
Date Cleared
2013-08-22
(232 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TRIGG LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trigg Laboratories Wet Platinum Premium 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, polyisoprene, and polyurethane condoms.
Device Description
The Wet Platinum Premium Lubricant® is a non-sterile, silicone based personal lubricant, an over-the-counter personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. It is a Silicone soluble, gel-like liquid for use as a personal lubricant. The Wet Platinum Premium Lubricant® contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.
The specifications for Wet Platinum include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable specifications because the subject lubricant is anhydrous.
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K Number
K013086Device Name
WET LIGHT PERSONAL MOISTURIZER
Manufacturer
TRIGG LABORATORIES, INC.
Date Cleared
2001-12-13
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TRIGG LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WET® Light Personal Moisturizer is intended for which Bight refections. It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.
Device Description
Not Found
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