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FDA 510(k)

Lifestyles Zero Lubricated Latex Male Condom

K-Number: K163107 · 2017-01-23

ApplicantAnsell Healthcare Products, LLC
Decision Date2017-01-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Lifestyles Zero Lubricated Latex Male Condom is a medical device manufactured by Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-01-23 under approval number K163107. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lifestyles Zero Lubricated Latex Male Condom?

Lifestyles Zero Lubricated Latex Male Condom is a medical device that received FDA 510(k) clearance on 2017-01-23. It is manufactured by Ansell Healthcare Products, LLC. The 510(k) number is K163107.

When was Lifestyles Zero Lubricated Latex Male Condom approved by the FDA?

Lifestyles Zero Lubricated Latex Male Condom received FDA 510(k) clearance on 2017-01-23, under approval number K163107.

What company makes Lifestyles Zero Lubricated Latex Male Condom?

Lifestyles Zero Lubricated Latex Male Condom is manufactured by Ansell Healthcare Products, LLC.

What is the FDA product code for Lifestyles Zero Lubricated Latex Male Condom?

The FDA product code for Lifestyles Zero Lubricated Latex Male Condom is HIS.

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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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