Product Code: NEC FDA class 1 21 CFR 880.5090

Bandage, Liquid, Skin Protectant

General Hospital

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.

510(k)s
3
FEI Numbers
142
Registration Numbers
142
Unique Applicants
2
Years Active
12

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 3 510(k) clearances via K numbers.

K Number Device Name
K972081 SUPERSKIN
K861557 APLICARE SKIN PROTECTANT PREP PAD
K861558 APLICARE SKIN PROTECTANT SWABSTICK

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.