| Device Type ID | 5474 |
| Device Name | Bandage, Liquid, Skin Protectant |
| Regulation Description | Liquid Bandage. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5090 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NEC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5474 |
| Device | Bandage, Liquid, Skin Protectant |
| Product Code | NEC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Liquid Bandage. |
| CFR Regulation Number | 880.5090 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Increased Sensitivity | 2 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioDerm, Inc. | II | Jun-10-2014 |
| 2 | MEDLINE INDUSTRIES INC | II | Oct-06-2018 |
| 3 | Safe N Simple, LLC | II | Jun-29-2018 |