QUALTEX ISLAND DRESSING
Device Facts
| Record ID | K910657 |
|---|---|
| Device Name | QUALTEX ISLAND DRESSING |
| Applicant | Deroyal Industries, Inc. |
| Product Code | KGX · General Hospital |
| Decision Date | Jul 1, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.