510(k) K223519
K223519 is an FDA 510(k) premarket notification submitted by Karex Industries Sdn. Bhd. for the device "Carex Hybrid Personal Lubricant". The FDA issued a decision of Substantially Equivalent on August 11, 2023. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Karex Industries Sdn. Bhd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2023
- Date Received
- November 23, 2022
- Clearance Type
- Abbreviated
- 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
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.