21 CFR 880.5630 — Shield, Nipple
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5630
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HFS | Shield, Nipple | 1 | 12 | |
| NTC | Nursing Pad, Hydrogel | 1 | 1 | |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | 1 | 1 | |
| NXH | Nursing Pad, Cohesive Gel | 1 | 1 |
