21 CFR 880.5630
§ 880.5630 Nipple shield.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5630, § 880.5630 Nipple shield, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90548
- Permanent ID
ys:prov:90548@1- SHA-256
a9350d8a4ffcf208fc4d120ae80f2d6ec80dc0ce4440f63ce6f2570241f11b56
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.