| Device Type ID | 4021 |
| Device Name | Condom, Synthetic |
| 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 | MOL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 4021 |
| Device | Condom, Synthetic |
| Product Code | MOL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Condom. |
| CFR Regulation Number | 884.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANSELL HEALTHCARE PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHURCH & DWIGHT CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SXWELL USA LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Cross Reactivity | 4 |
Device Emits Odor | 3 |
Material Rupture | 2 |
Split | 1 |
Insufficient Information | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Contamination During Use | 1 |
Patient-Device Incompatibility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 17 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Reckitt Benckiser LLC | II | Mar-09-2019 |
| 2 | Reckitt Benckiser LLC | II | Oct-10-2018 |
| 3 | Reckitt Benckiser LLC | II | Sep-24-2018 |