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510(k) Data Aggregation
K Number
K171172Device Name
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Manufacturer
Ansell Healthcare Products LLC.
Date Cleared
2017-08-02
(103 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
Device Description
The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
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