§ 880.5630. Nipple shield.
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/us/cfr/t21/s§ 880.5630·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 33804, July 25, 2001]