# K223559: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

- Pathway: 510(k) (Abbreviated)
- Applicant: Nephron Pharmaceuticals Corporation
- Decided: Feb 9, 2023 after 73 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: 8 generations back to K042805 (2004). 9 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K213440: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs, Luliang Hongruida Health Protection Technology Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K231349: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) (2023), 2 descendants of its own
- 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) 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 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

Source page: https://510kreport.com/device/K223559
Methodology: https://510kreport.com/methodology