Bandage, Liquid, Skin Protectant
The Bandage, Liquid, Skin Protectant (product code NEC) is a topical product applied to skin that forms a protective liquid bandage film to cover minor cuts, abrasions, or skin irritations. It is classified as an FDA Class 1 device within the General Hospital specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NEC
- Device Class
- FDA class 1
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972081 | SUPERSKIN | Dec 17, 1997 | Substantially Equivalent | Medlogic Global Corp. |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | Jul 11, 1986 | Substantially Equivalent | Aplicare, Inc. |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | Jun 04, 1986 | Substantially Equivalent | Aplicare, Inc. |
FEI Numbers
This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 142 registration numbers. Click on an entry to view related FDA registrations.