Natural rubber latex male condom
K-Number: K250034 · 2025-07-11
Decision Date2025-07-11
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Natural rubber latex male condom is a medical device manufactured by Shaoguan Regenex Pharmaceuticals Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under approval number K250034. 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 Natural rubber latex male condom?
Natural rubber latex male condom is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Shaoguan Regenex Pharmaceuticals Co., Ltd.. The 510(k) number is K250034.
When was Natural rubber latex male condom approved by the FDA?
Natural rubber latex male condom received FDA 510(k) clearance on 2025-07-11, under approval number K250034.
What company makes Natural rubber latex male condom?
Natural rubber latex male condom is manufactured by Shaoguan Regenex Pharmaceuticals Co., Ltd..
What is the FDA product code for Natural rubber latex male condom?
The FDA product code for Natural rubber 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.