# K240080: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Syntex Healthcare Products Co., Ltd.
- Decided: Apr 2, 2024 after 82 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 K082457 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200671: Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for, Ansell Healthcare Products, LLC (2020) Summary page 6.

## Most influential descendants
- K243694: Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (2025), 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) The following chemicals have been tested with these gloves: Chemotherapy Drug Minimum Breakthrough Detection Time in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 21.2 Cisplatin, Img/ml (1000 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 (5 Flu), 50mg/ml (50,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin C, 0.5mg/ml (500 ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 24.9 Vincristine sulfate, 1mg/ml (1000 ppm) >240 Fentanyl Citrate Minimum Breakthrough Detection Time in Minutes Fentanyl Citrate Injection, 100mcg/2mg >240 *Please note that the following drugs have extremely low permeation times: Carmustine: 21.2 minutes, Thio Tepa: 24.9minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K240080
Methodology: https://510kreport.com/methodology