K-number	K160399
Device name	Skyn Original Polyisoprene Lubricated Male Condom
Applicant	Ansell Healthcare Products, LLC
Product code	MOL
Device class	Class II
Decision date	Jul 25, 2016
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Skyn Original Polyisoprene Lubricated Male Condom

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