| Device |
personal lubricant ring |
| Regulation Description |
Condom. |
| Definition |
This device is a personal lubricant, for 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, polyurethane, and/or internal condoms. |
| Physical State |
This device consists of a hollow plastic ring filled with a liquid vaginal lubricating solution. |
| Technical Method |
The lubricating solution in the lumen of the ring is released through the wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa. |
| Target Area |
This device is intended to be used in the vagina. |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | QPD |
|---|
| Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
884.5300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
