# K234097: Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Ever Growth (Vietnam) Corporation Limited
- Decided: Mar 27, 2024 after 92 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: 7 generations back to K042805 (2004). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190736: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs, Ever Growth (Vietnam) Co., Ltd. (2019) Summary page 6.

## Indications for use
A non-powdered patient examination glove 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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. No. Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Min.)* 1 Bleomycin Sulfate 15.0 mg/ml > 240 2 Busulfan 6.0 mg/ml > 240 3 Carboplatin 10.0 mg/ml > 240 4 Carmustine (BCNU) 3.3 mg/ml 59.4 5 Chloroquine 50.0 mg/ml > 240 6 Cisplatin 1 mg/ml > 240 7 Cyclophosphamide 20 mg/ml > 240 8 Cyclosporin A 100.0 mg/ml > 240 9 Cytarabine 100.0 mg/ml > 240 10 Dacarbazine (DTIC), 10.0 mg/ml > 240 11 Daunorubicin 5.0 mg/ml > 240 12 Docetaxel 10.0 mg/ml > 240 13 Doxorubicin Hydrochloride 2.0 mg/ml > 240 14 Epirubicin 2.0 mg/ml > 240 15 Etoposide (Toposar) 20.0 mg/ml > 240 16 Fludarabine 25.0 mg/ml > 240 17 Fluorouracil 50.0 mg/ml > 240 18 Gemcitabine 38.0 mg/ml > 240 19 Idaribicin 1.0 mg/ml > 240 20 Ifosfamide 50.0 mg/ml > 240 21 Irinotecan 20.0 mg/ml > 240 22 Mechlorethamine HCl 1.0 mg/ml > 240 23 Melphalan 5.0 mg/ml > 240 24 Methotrexate 25 mg/ml > 240 25 Mitomycin C 0.5 mg/ml > 240 26 Mitoxantrone 2.0 mg/ml > 240 27 Oxaliplatin 2.0 mg/ml > 240 28 Paclitaxel (Taxol), 6.0 mg/ml > 240 29 Paraplatin 10 mg/ml > 240 30 Retrovir 10 mg/ml > 240 31 Rituximab 10 mg/ml > 240 32 Thiotepa, 10.0 mg/ml 118.5 33 Topotecan HCl 1.0 mg/ml > 240 34 Trisonex 1.0 mg/ml > 240 35 Velcade (Bortezomib) 1.0 mg/ml > 240 36 Vincristine 1.0 mg/ml > 240 Fentanyl Citrate Test Fentanyl Citrate Injection 100 mcg/2ml >240 Thiotepa and Carmustine have low permeation times

Source page: https://510kreport.com/device/K234097
Methodology: https://510kreport.com/methodology