K150094 is an FDA 510(k) clearance for the Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Good Clean Love, Inc. (Eugene, US). The FDA issued a Cleared decision on November 19, 2015, 307 days after receiving the submission on January 16, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300. 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..
| 510(k) Number | K150094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2015 |
| Decision Date | November 19, 2015 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NUC - Lubricant, Personal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |
| Definition | 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. |