Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349)
Description
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) by Nephron Nitrile, LLC, an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231349
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (K231349) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tes... | Nephron Pharmaceuticals Corporation | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Bl... | Nephron Nitrile, LLC | 2024 |
| K233970 | Nephron Nitrile™, Nitrile Powder-Free Examination Blue Glov... | Nephron Nitrile, LLC | 2024 |
Trace the full predicate network for K231349
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.