OneTouch Lubricant Gel— 510(k) K142790

Substantially Equivalent

Thai Nippon Rubber Industry Co., Ltd.

FDA 510(k) clearance K142790 for OneTouch Lubricant Gel, Substantially Equivalent on 2015-07-30. Applicant: Thai Nippon Rubber Industry Co., Ltd..

Clearance details

Applicant: Thai Nippon Rubber Industry Co., Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2014-09-26
Decision date: 2015-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sriracha, TH

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.