Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
The Polyurethane Nursing Pad with Starch Copolymer, Glycerin, and Surfactant (F-68) is a breastfeeding accessory designed to relieve nipples that are sore and cracked from breastfeeding by providing moisture through its glycerin-containing composition. It is an FDA Class 1 device regulated under 21 CFR 880.5630 in the General Hospital specialty, with product code NTX, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
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Basic Information
- Product Code
- NTX
- Device Class
- FDA class 1
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031660 | FERRIS POLYMEM STERILE BREAST PAD | Feb 22, 2005 | Substantially Equivalent | Ferris Mfg. Corp. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.