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510(k) Data Aggregation
K Number
K150147Device Name
Lubrigyn cream
Manufacturer
Date Cleared
2015-02-19
(28 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
UNIDERM FARMACEUTICI SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Device Description
LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in a 50 mail airless container and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort. The specifications for the LUBRIGYN CREAM include appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).
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K Number
K132772Device Name
LUBRIGYN CREAM
Manufacturer
Date Cleared
2014-08-22
(351 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
UNIDERM FARMACEUTICI SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Device Description
LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in single use pouches and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort.
The specifications for the LUBRIGYN CREAM include appearance, color, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).
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Ask a specific question about this device
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