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
| Device Type ID | 4046 |
| Device Name | Lubricant, Personal |
| 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 | NUC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4046 |
| Device | Lubricant, Personal |
| Product Code | NUC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Condom. |
| CFR Regulation Number | 884.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOFILM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARRASHIELD LABS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CC WELLNESS LLC | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
CHURCH & DWIGHT CO., INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHURCH & DWIGHT CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
EMPOWERED PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FARMA-DERMA S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIDIA FARMACEUTICI SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GOOD CLEAN LOVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GUY & O'NEILL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ICM PHARMA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LACLEDE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LOVE ALCHEMY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NATUREPLEX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEO COSMETIQUE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PERRIGO COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PJUR GROUP LUXEMBOURG SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PJUR GROUP,LUXEMBOURG S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLICHEM S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RECKITT BENCKISER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RECKITT BENCKISER LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
RECKITT BENCKISER, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIMPLY SOLUTIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SXWELL USA LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THAI NIPPON RUBBER INDUSTRY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE KAMA SUTRA COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOASTER LABS, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
UNIDERM FARMACEUTICI SRL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
UNITED CONSORTIUM INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTRIDGE LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 13 |
Cross Reactivity | 2 |
Unexpected Therapeutic Results | 1 |
| Total Device Problems | 16 |