NEC · Bandage, Liquid, Skin Protectant
General Hospital · 21 CFR 880.5090 · Class 1
Overview
| Product Code | NEC |
|---|---|
| Device Name | Bandage, Liquid, Skin Protectant |
| Regulation | 21 CFR 880.5090 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.
Classification Rationale
Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972081 | SUPERSKIN | Medlogic Global Corp. | Dec 17, 1997 | SESE |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | Aplicare, Inc. | Jul 11, 1986 | SESE |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | Aplicare, Inc. | Jun 4, 1986 | SESE |
Top Applicants
- Aplicare, Inc. — 2 clearances
- Medlogic Global Corp. — 1 clearance
