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Lubricant, Personal

FDA product code NUC · 217 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.5300
Review panel
OB
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2000-08-02 – 2026-09-23

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.

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