← FDA Medical Device Classifications
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
NTX · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.5630
Classification
- FDA Product Code
NTX- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 880.5630
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 55
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown