# K233970: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

- Pathway: 510(k) (Special)
- Applicant: Nephron Nitrile, LLC
- Decided: Jan 16, 2024 after 32 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: 10 generations back to K042805 (2004). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231349: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl), Nephron Nitrile, LLC (2023) Summary page 6.

## Indications for use
Nephron Nitrile™, Nitrile Powder-Free Examination Blue 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) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 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/K233970
Methodology: https://510kreport.com/methodology