# K233990: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Xingyu Gloves Co., Ltd.
- Decided: Apr 1, 2024 after 105 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: 6 generations back to K000323 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223903: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105), Semperit Investments Asia Pte, Ltd. (2023) Summary page 6.

## Indications for use
The Nitrile Disposable Examination Glove, 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. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy 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) 13.2 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) 13.1 Vincristine Sulfate (1.0 mg/mIL 1,000 ppm >240 min The tested non-chemotherapy drugs are: Fentanyl Citrate Injection (100 mcg/2mL) >240 min MESNA (100.0 mg/mL 100,000 ppm) >240 min Trisenox (1.0 mg/ml 1,000 ppm) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

Source page: https://510kreport.com/device/K233990
Methodology: https://510kreport.com/methodology