§ 878.4014. Nonresorbable gauze/sponge for external use.
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/us/cfr/t21/s§ 878.4014·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use 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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§ 878.4014
Nonresorbable gauze/sponge for external use.
Fed. Reg.×4
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