# K240629: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Xingyu Medical Tech Co., Ltd.
- Decided: May 28, 2024 after 83 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: 4 generations back to K183287 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min Carboplatin (10.0 mg/ml 10,000 ppm) 240 min Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7 Cisplatin (1.0 mg/mL 1,000 ppm) 240 min Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min Idarubicin (1.0 mg/ml 1,000 ppm) 240 min Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min Methotrexate (25.0 mg/mL 25,000 ppm) 240 min Mitomycin C (0.5 mg/mL 500 ppm) 240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min Thiotepa (10.0 mg/mL 10,000 ppm) 37.6 Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min Non Chemotherapy Drug MESNA (100.0 mg/mL 100,000 ppm) 240 min Trisenox (1.0 mg/ml 1,000 ppm) 240 min Fentanyl Citrate Injection (100 mcg/2mL) 240 min Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa.

Source page: https://510kreport.com/device/K240629
Methodology: https://510kreport.com/methodology