# K240545: GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

- Pathway: 510(k) (Traditional)
- Applicant: Genabio Diagnostics, Inc.
- Decided: Aug 28, 2024 after 183 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.
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)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 6.

## Most influential descendants
- K242936: Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2025), 0 descendants of its own

## Indications for use
The GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carmustine 3.3 mg/ml 22.8 Minutes Cisplatin 1.0 mg/ml > 240 Minutes Cyclophosphamide 20.0 mg/ml > 240 Minutes Dacarbazine 10.0 mg/ml > 240 Minutes Doxorubicin HCI 2.0 mg/ml > 240 Minutes Etoposide 20.0 mg/ml > 240 Minutes Fluorouracil 50.0 mg/ml > 240 Minutes Methotrexate 25.0 mg/ml > 240 Minutes Mitomycin C 0.5 mg/ml > 240 Minutes Paclitaxel 6.0 mg/ml > 240 Minutes Thiotepa 10.0 mg/ml 37.9 Minutes Vincristine Sulfate 1.0 mg/ml > 240 Minutes Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time Fentanyl Citrate Injection 100.0mcg/2ml > 240 Minutes Please note that the following drugs have low permeation time: Carmustine 3.3 mg/ml 22.8 Minutes; Thiotepa 10.0 mg/ml 37.9 Minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K240545
Methodology: https://510kreport.com/methodology