Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5630](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5630) → NTX — Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)

# NTX · Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)

_General Hospital · 21 CFR 880.5630 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTX

## Overview

- **Product Code:** NTX
- **Device Name:** Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
- **Regulation:** [21 CFR 880.5630](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5630)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTX/K031660.md) | FERRIS POLYMEM STERILE BREAST PAD | Ferris Mfg. Corp. | Feb 22, 2005 | SESE |

## Top Applicants

- Ferris Mfg. Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTX](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NTX)

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