| Device Type ID | 1699 |
| Device Name | Garment, Protective, For Incontinence |
| Regulation Description | Protective Garment For Incontinence. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5920 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EYQ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1699 |
| Device | Garment, Protective, For Incontinence |
| Product Code | EYQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Protective Garment For Incontinence. |
| CFR Regulation Number | 876.5920 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Break | 3 |
Material Split, Cut Or Torn | 2 |
Patient-Device Incompatibility | 2 |
Clumping In Device Or Device Ingredient | 1 |
Device Appears To Trigger Rejection | 1 |
Physical Property Issue | 1 |
Material Separation | 1 |
| Total Device Problems | 22 |