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FDA 510(k)

Water Solubility Human Body Lubricant

K-Number: K243107 · 2025-05-09

ApplicantDongguan Yanxuan Biotechnology Co., Ltd.
Decision Date2025-05-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Water Solubility Human Body Lubricant is a medical device manufactured by Dongguan Yanxuan Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under approval number K243107. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Water Solubility Human Body Lubricant?

Water Solubility Human Body Lubricant is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Dongguan Yanxuan Biotechnology Co., Ltd.. The 510(k) number is K243107.

When was Water Solubility Human Body Lubricant approved by the FDA?

Water Solubility Human Body Lubricant received FDA 510(k) clearance on 2025-05-09, under approval number K243107.

What company makes Water Solubility Human Body Lubricant?

Water Solubility Human Body Lubricant is manufactured by Dongguan Yanxuan Biotechnology Co., Ltd..

What is the FDA product code for Water Solubility Human Body Lubricant?

The FDA product code for Water Solubility Human Body Lubricant is NUC.

Related PubMed Literature

PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026) PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

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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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