# K231349: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

- Pathway: 510(k) (Special)
- Applicant: Nephron Nitrile, LLC
- Decided: Jun 6, 2023 after 28 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K042805 (2004). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223559: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs), Nephron Pharmaceuticals Corporation (2023) Summary page 4.

## Most influential descendants
- K232654: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) (2024), 0 descendants of its own
- K233970: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (2024), 0 descendants of its own

## Indications for use
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Bleomycin Sulfate (15.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Busulfan (6.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Melphalan (5.0 mg/ml) Carboplatin (10.0 mg/ml) Etoposide (20.0 mg/ml) Methotrexate (25.0 mg/ml) Cisplatin (1.0 mg/ml) Fludarabine (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Cyclophosphamide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Cytarabine (100.0 mg/ml) Gemcitabine (38.0 mg/ml) Paclitaxel (6.0 mg/ml) Dacarbazine (10.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Rituximab (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Ifosfamide (50.0 mg/ml) Trisenox (1.0 mg/ml) Docetaxel (10.0 mg/ml) Irinotecan (20.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes Warning: Not for Use with: Carmustine, Thiotepa The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL). Permeation: no breakthrough up to 240 minutes

Source page: https://510kreport.com/device/K231349
Methodology: https://510kreport.com/methodology