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878.4022—Hydrogel wound dressing and burn dressing.

(a) Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

Code of Federal Regulations

[64 FR 53929, Oct. 5, 1999]

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