510(k) K220534
K220534 is an FDA 510(k) premarket notification submitted by Trigg Laboratories, Inc. for the device "Wet Essential95 Personal Lubricant". The FDA issued a decision of Substantially Equivalent on Jul 7, 2022. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Trigg Laboratories, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2022
- Date Received
- Feb 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)
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.