NUC · Class II · 21 CFR 884.5300

FDA Product Code NUC: Lubricant, Personal

This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.

Leading manufacturers include Church & Dwight Co., Inc..

1
Total
1
Cleared
164d
Avg days
2021
Since

List of Lubricant, Personal devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Jun 11, 2021
Replens Long-Lasting Vaginal Moisturizer
K203818
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 164d

How to use this database

This page lists all FDA 510(k) submissions for Lubricant, Personal devices (product code NUC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Obstetrics & Gynecology FDA review panel. Browse all Obstetrics & Gynecology devices →