K133336 is an FDA 510(k) clearance for the PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE. This device is classified as a Lubricant, Personal (Class II - Special Controls, product code NUC).
Submitted by Pjur Group Luxembourg S.A. (Wilmington, US). The FDA issued a Cleared decision on July 24, 2014, 268 days after receiving the submission on October 29, 2013.
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 | K133336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2013 |
| Decision Date | July 24, 2014 |
| Days to Decision | 268 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. |