510(k) K150743
K150743 is an FDA 510(k) premarket notification submitted by Karex Industries Sdn. Bhd. for the device "Water Based Personal Lubricant with Flavours". The FDA issued a decision of Substantially Equivalent on Nov 12, 2015. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Karex Industries Sdn. Bhd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 12, 2015
- Date Received
- Mar 23, 2015
- 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
- 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.