21 CFR 880.5090 — Bandage, Liquid

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5090

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KMFBandage, Liquid12223rd Party
NECBandage, Liquid, Skin Protectant13
Innolitics

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