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FDA 510(k)

Synthetic Polyisoprene Lubricated Male Condom - 5 senses

K-Number: K182438 · 2018-12-06

ApplicantSxwell USA, LLC
Decision Date2018-12-06
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Synthetic Polyisoprene Lubricated Male Condom - 5 senses is a medical device manufactured by Sxwell USA, LLC. It received FDA 510(k) clearance on 2018-12-06 under approval number K182438. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

Synthetic Polyisoprene Lubricated Male Condom - 5 senses is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Sxwell USA, LLC. The 510(k) number is K182438.

When was Synthetic Polyisoprene Lubricated Male Condom - 5 senses approved by the FDA?

Synthetic Polyisoprene Lubricated Male Condom - 5 senses received FDA 510(k) clearance on 2018-12-06, under approval number K182438.

What company makes Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

Synthetic Polyisoprene Lubricated Male Condom - 5 senses is manufactured by Sxwell USA, LLC.

What is the FDA product code for Synthetic Polyisoprene Lubricated Male Condom - 5 senses?

The FDA product code for Synthetic Polyisoprene Lubricated Male Condom - 5 senses is MOL.

Other Devices by Sxwell USA, LLC

K172473LifeStyles® SKYN® Intimate Moments Personal Lubricant

Related Devices (Code: MOL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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