# K230779: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Shanxi Hongjin Plastic Technology Co., Ltd.
- Decided: Jun 9, 2023 after 80 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: 2 generations back to K183287 (2019). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 4.

## Most influential descendants
- K243792: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) (2025), 0 descendants of its own
- K232353: Powder Free Nitrile Examination Gloves (Black) (2023), 0 descendants of its own

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 11.3 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 24.7 Fentanyl Citrate Injection (100 mcg/2ml) >240 Please note that the following drugs have extremely low permeation times: Carmustine: 11.3 minutes, Thio Tepa: 24.7 minutes *Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K230779
Methodology: https://510kreport.com/methodology