§ 878.4022. Hydrogel wound dressing and burn dressing.
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/us/cfr/t21/s§ 878.4022·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [64 FR 53929, Oct. 5, 1999]
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§ 878.4022
Hydrogel wound dressing and burn dressing.
Fed. Reg.×1
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