K-number	K232470
Device name	Polyisoprene Extra Large Condom
Applicant	Suretex Limited
Product code	MOL
Device class	Class II
Decision date	May 9, 2024
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Polyisoprene Extra Large Condom

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