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) → HFS — Shield, Nipple

# HFS · Shield, Nipple

_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/HFS

## Overview

- **Product Code:** HFS
- **Device Name:** Shield, Nipple
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K944177](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K944177.md) | BREAST SHELL | O'Donnell, Byrne & Williams | Oct 5, 1994 | SESE |
| [K944117](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K944117.md) | AVENT NIPPLE SHIELD | Avent America, Inc. | Oct 5, 1994 | SESE |
| [K935341](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K935341.md) | COMFORT PLUS BREAST SHELLS | Marshall Baby Products | Jan 21, 1994 | SESE |
| [K935340](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K935340.md) | COMFORT PLUS NIPPLE SHIELDS | Marshall Baby Products | Jan 21, 1994 | SESE |
| [K930238](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K930238.md) | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS | Prolac, Inc. | Aug 16, 1993 | SESE |
| [K923577](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K923577.md) | BREAST SHELLS | Medela, Inc. | Jan 22, 1993 | SESE |
| [K864176](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K864176.md) | GENTLE FEEL | Mali, Inc. | Nov 4, 1986 | SESE |
| [K861608](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K861608.md) | UNICARE BREAST SHELLS | Unicare Medical Products, Inc. | Jul 15, 1986 | SESE |
| [K853176](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K853176.md) | CANNON BABYSAFE NIPPLE SHIELDS | Medela, Inc. | Aug 22, 1985 | SESE |
| [K840877](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K840877.md) | ARGYLE ENTERNAL FEEDING BAG W/ADMIN | Sherwood Medical Co. | Jun 28, 1984 | SESE |
| [K833450](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K833450.md) | NUK BREAST SHIELD | Reliance Products Corp. | Nov 21, 1983 | SESE |
| [K811364](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS/K811364.md) | AXICARE BREAST SHELL | Neonatal Corp. | Aug 3, 1981 | SESE |

## Top Applicants

- Marshall Baby Products — 2 clearances
- Medela, Inc. — 2 clearances
- Avent America, Inc. — 1 clearance
- Mali, Inc. — 1 clearance
- Neonatal 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/HFS](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/HFS)

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