510(k) K212104
K212104 is an FDA 510(k) premarket notification submitted by Foshan Pingchuang Medical Technology Co., Ltd. for the device "Water-soluble Personal Lubricant". The FDA issued a decision of Substantially Equivalent on November 18, 2021. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Foshan Pingchuang Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2021
- Date Received
- July 6, 2021
- 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
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.