510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NTXClass I

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

21 CFR 880.5630 / General Hospital
FDA source (opens on fda.gov)

NTX is the FDA product code for Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68), a class I device type, regulated under 21 CFR 880.5630. FDA's definition for this code reads: "A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NTX
Device name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
FDA definition
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NTX

By decision year
1 clearance under product code NTX with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NTX by decision year
YearClearances
20051

Applicants with the most clearances

Product code NTX
Applicants holding the most 510(k) clearances under product code NTX
ApplicantClearances
Ferris Mfg. Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order