# K031660: Ferris Polymem Sterile Breast Pad

- Pathway: 510(k) (Traditional)
- Applicant: Ferris Mfg. Corp.
- Decided: Feb 22, 2005 after 636 days
- Product code: NTX (Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68))
- Device class: 1
- Regulation: 21 CFR 880.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Over the Counter Use: To be worn inside the bra to: Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding Absorb milk leakage Protect the nipple from abrasion and friction damage caused by bra or clothing Help alleviate discomfort Protect clothing from milk leakage

Source page: https://510kreport.com/device/K031660
Methodology: https://510kreport.com/methodology