SILICONE Personal Lubricant— 510(k) K191654

Substantially Equivalent

Bath Concept Cosmetics (Dongguan) Co., Ltd.

FDA 510(k) clearance K191654 for SILICONE Personal Lubricant, Substantially Equivalent on 2020-04-14. Applicant: Bath Concept Cosmetics (Dongguan) Co., Ltd..

Clearance details

Applicant: Bath Concept Cosmetics (Dongguan) Co., Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-20
Decision date: 2020-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.