pjur NATURE Touch, 100 ml
FDA 510(k) K260068 · Pjur Group Luxembourg S.A.
510(k) numberK260068
Submission
- Device name
- pjur NATURE Touch, 100 ml
- Applicant
- Pjur Group Luxembourg S.A.
Wasserbillig, LU - Received
- January 9, 2026
- Decision date
- May 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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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Questions and answers
When was pjur NATURE Touch, 100 ml cleared by the FDA?
pjur NATURE Touch, 100 ml (K260068) received a 510(k) decision of Substantially Equivalent on May 21, 2026, 132 days after the submission was received.
What is the product code of K260068?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.