Definition: A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural
| Device Type ID | 4079 |
| Device Name | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Physical State | Liquid Or Gel |
| Technical Method | Coats Vaginal And/or Penile Tissue To Reduce Friction During Sexual Activity With Or Without A Condom; Is Non-toxic To Sperm, Oocytes, And Developing Embryos And Does Not Interfere With The Fertilization Process; Lubricates Devices Used During Fertil |
| Target Area | Vagina And/or Penis |
| Regulation Description | Condom. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4079 |
| Device | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
| Product Code | PEB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Condom. |
| CFR Regulation Number | 884.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOFILM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |