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FDA 510(k)

Bloomi Smooth Water Based Lubricant

K-Number: K221328 · 2022-08-04

ApplicantThe Bloomi Inc..
Decision Date2022-08-04
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Bloomi Smooth Water Based Lubricant is a medical device manufactured by The Bloomi Inc... It received FDA 510(k) clearance on 2022-08-04 under approval number K221328. 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 Bloomi Smooth Water Based Lubricant?

Bloomi Smooth Water Based Lubricant is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by The Bloomi Inc... The 510(k) number is K221328.

When was Bloomi Smooth Water Based Lubricant approved by the FDA?

Bloomi Smooth Water Based Lubricant received FDA 510(k) clearance on 2022-08-04, under approval number K221328.

What company makes Bloomi Smooth Water Based Lubricant?

Bloomi Smooth Water Based Lubricant is manufactured by The Bloomi Inc...

What is the FDA product code for Bloomi Smooth Water Based Lubricant?

The FDA product code for Bloomi Smooth Water Based Lubricant is NUC.

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Related PubMed Literature

PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

Other Devices by The Bloomi Inc..

K222175Bloomi Delight Oil-Based Personal Lubricant

Related Devices (Code: NUC)

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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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