NXH · Nursing Pad, Cohesive Gel
General Hospital · 21 CFR 880.5630 · Class 1
Overview
| Product Code | NXH |
|---|---|
| Device Name | Nursing Pad, Cohesive Gel |
| Regulation | 21 CFR 880.5630 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052858 | SOOTHIES GEL PADS | Puronxy, Inc. | Feb 9, 2006 | SESE |
Top Applicants
- Puronxy, Inc. — 1 clearance
