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FDA 510(k)

LifeStyles® HydraFeel Natural Rubber Latex Condom

K-Number: K252521 · 2025-11-18

ApplicantSuretex Limited
Decision Date2025-11-18
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LifeStyles® HydraFeel Natural Rubber Latex Condom is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2025-11-18 under approval number K252521. 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® HydraFeel Natural Rubber Latex Condom?

LifeStyles® HydraFeel Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Suretex Limited. The 510(k) number is K252521.

When was LifeStyles® HydraFeel Natural Rubber Latex Condom approved by the FDA?

LifeStyles® HydraFeel Natural Rubber Latex Condom received FDA 510(k) clearance on 2025-11-18, under approval number K252521.

What company makes LifeStyles® HydraFeel Natural Rubber Latex Condom?

LifeStyles® HydraFeel Natural Rubber Latex Condom is manufactured by Suretex Limited.

What is the FDA product code for LifeStyles® HydraFeel Natural Rubber Latex Condom?

The FDA product code for LifeStyles® HydraFeel Natural Rubber Latex Condom is HIS.

Other Devices by Suretex Limited

K221243OFNat Lubricant (L15) K213921Microthin Natural Rubber Latex Condom K23190845 Micron Polyisoprene Condom K232279LifeStyles NRL Textured Condom K232470Polyisoprene Extra Large Condom

Related Devices (Code: 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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