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Water-soluble Personal Lubricant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212104

by Foshan Pingchuang Medical Technology Co., Ltd

Identifiers

510(k) Number
K212104 FDA 510(k)
FDA Product Code
NUC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Lubricant, Personal (FDA product code NUC), designed to reduce friction and discomfort during intimate activities. It is formulated to be water-soluble, ensuring ease of removal with water and minimizing residue. The product is intended for use in obstetrics and gynecology settings, adhering to regulatory standards for Class II medical devices.

Supplied as a single-use, non-sterile formulation, this lubricant is intended for external application only. It is regulated under 21 CFR § 884.5300 and cleared through the FDA’s Traditional 510(k) pathway following a review by the Obstetrics (OB) Advisory Committee. No third-party involvement is noted in its regulatory submission. Storage conditions are not specified in the data, but standard room temperature storage is implied for non-sterile medical devices.

Frequently asked questions

Is this lubricant intended for internal use during medical procedures, or is it strictly for external application only?

This water-soluble personal lubricant is explicitly designed for external application only, as stated in the device description. While it is intended for use in obstetrics and gynecology settings, it is not meant for internal insertion or use within body cavities.

How is this lubricant packaged and supplied for clinical use?

The lubricant is supplied as a single-use formulation, meaning each application requires a new unit. Since it is non-sterile, it is not intended for sterile procedures, and standard room-temperature storage is implied for non-sterile medical devices. Specific packaging details (e.g., tube size, applicator type) are not provided in the data.

What regulatory pathway was followed for FDA clearance of this lubricant, and which advisory committee reviewed it?

This lubricant was cleared through the FDA’s Traditional 510(k) pathway, reviewed by the Obstetrics (OB) Advisory Committee. The decision was based on a determination of substantial equivalence (SESE) under 21 CFR § 884.5300, with no third-party involvement in the submission process.

Can this lubricant be reused after application, or is it designed for one-time use?

The lubricant is explicitly labeled as single-use, meaning it should not be reused after application. This aligns with standard practices for personal lubricants to ensure hygiene and prevent contamination, particularly in clinical settings.

What medical specialties or clinical settings is this lubricant primarily intended for?

This lubricant is primarily intended for obstetrics and gynecology settings, as noted in the device description and regulatory submission. Its formulation and regulatory classification (FDA product code NUC) reflect its use in reducing friction and discomfort during procedures or activities within these specialties.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Foshan Pingchuang Medical Technology Co., Ltd. FDA 510 (k), K212104 - Water-soluble Personal Lubricant | FDA 510 (k), Water-soluble Personal Lubricant (K212104) — FDA 510 (k) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foshan Pingchuang Medical Technology Co., Ltd
FDA Applicant
Foshan Pingchuang Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K212104 24 fields · synced Sep 20, 2026