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FDA 510(k)

Water-soluble Personal Lubricant

K-Number: K212104 · 2021-11-18

ApplicantFoshan Pingchuang Medical Technology Co., Ltd.
Decision Date2021-11-18
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Water-soluble Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K212104. 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-soluble Personal Lubricant?

Water-soluble Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. The 510(k) number is K212104.

When did Water-soluble Personal Lubricant receive FDA 510(k) clearance?

Water-soluble Personal Lubricant received FDA 510(k) clearance on 2021-11-18, under 510(k) number K212104.

Who is the listed applicant for Water-soluble Personal Lubricant?

The FDA 510(k) record lists Foshan Pingchuang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Water-soluble Personal Lubricant?

The FDA product code for Water-soluble Personal Lubricant is NUC.

Other records listing Foshan Pingchuang Medical Technology Co., Ltd. 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.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelK252935Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)

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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