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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 the device name listed in this FDA 510(k) record. The listed applicant is The Bloomi Inc... It received FDA 510(k) clearance on 2022-08-04 under 510(k) 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. The listed applicant is The Bloomi Inc... The 510(k) number is K221328.

When did Bloomi Smooth Water Based Lubricant receive FDA 510(k) clearance?

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

Who is the listed applicant for Bloomi Smooth Water Based Lubricant?

The FDA 510(k) record lists The Bloomi Inc.. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing The Bloomi Inc.. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222175Bloomi Delight Oil-Based Personal Lubricant

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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