NTX · Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
General Hospital · 21 CFR 880.5630 · Class 1
Overview
| Product Code | NTX |
|---|---|
| Device Name | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) |
| 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 |
|---|---|---|---|---|
| K031660 | FERRIS POLYMEM STERILE BREAST PAD | Ferris Mfg. Corp. | Feb 22, 2005 | SESE |
Top Applicants
- Ferris Mfg. Corp. — 1 clearance
