# K252244: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

- Pathway: 510(k) (Special)
- Applicant: Ever Global (Vietnam) Enterprise Corporation
- Decided: Aug 21, 2025 after 34 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: 8 generations back to K042805 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244034: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine, Ever Global (Vietnam) Enterprise Corporation (2025) Summary page 6.

## Indications for use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with cchemotherapy drugs, fentanyl citrate, xylazine, gastric acid, fentanyl in gastric acid and xylazine in gastric acid in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs. Tested Chemotherapy and Concentration(mg/ml) Minimum Breakthrough Detection Time(Min) Other Liquid Hazardous Drug 01 Arsenic Trioxide 1.0 > 240 02 Azacitidine (Vidaza) 25.0 > 240 03 Bendamustine HCl 5.0 > 240 04 Bleomycin Sulfate 15.0 > 240 05 Bortezomib (Velcade) 1.0 > 240 06 Busulfan 6.0 > 240 07 Carboplatin 10.0 > 240 08 Carfilzomib 2.0 > 240 09 Carmustine (BCNU) 3.3 21.5 10 Cetuximab (Erbitux) 2.0 > 240 11 Chloroquine 50.0 > 240 12 Cisplatin 1.0 > 240 13 Cladribine 1.0 > 240 14 Cyclophosphamide 20.0 > 240 15 Cyclosporine A 100.0 > 240 16 Cytarabine 100.0 > 240 17 Cytovene (Ganciclovir) 10.0 > 240 18 Dacarbazine 10.0 > 240 19 Daunorubicin 5.0 > 240 20 Decitabine 5.0 > 240 21 Docetaxel 10.0 > 240 22 Doxorubicin Hydrochloride 2.0 > 240 23 Epirubicin (Ellence) 2.0 > 240 24 Etoposide 20.0 > 240 25 Fludarabine 25.0 > 240 26 Fluorouracil 50.0 > 240 27 Fulvestrant 50.0 > 240 28 Gemcitabine 38.0 > 240 29 Idarubicin 1.0 > 240 30 Ifosfamide 50.0 > 240 31 Irinotecan 20.0 > 240 32 Mechlorethamine HCl 1.0 > 240 33 Melphalan 5.0 > 240 34 Methotrexate 25.0 > 240 35 Mesna 100.0 > 240 36 Mitomycin C 0.5 > 240 37 Mitoxantrone 2.0 > 240 38 Oxaliplatin 5.0 > 240 39 Paclitaxel 6.0 > 240 40 Paraplatin 10.0 > 240 41 Pemetrexed 25.0 > 240 42 Pertuzumab 30.0 > 240 43 Raltitrexed 0.5 > 240 44 Retrovir 10.0 > 240 45 Rituximab 10.0 > 240 46 Temsirolimus 25.0 > 240 47 Thiotepa 10.0 13.6 48 Topotecan HCl 1.0 > 240 49 Trastuzumab 21.0 > 240 50 Triclosan 2.0 > 240 51 Trisenox 1.0 > 240 52 Vinblastine 1.0 > 240 53 Vincristine Sulfate 1.0 > 240 54 Vinorelbine 10.0 > 240 55 Zoledronic Acid 0.8 > 240 56 Fentanyl Citrate 100.0 mcg/ 2.0 ml > 240 57 Xylazine HCl 100.0 > 240 58 Fentanyl Citrate Injection/ 100.0 mcg/ 2.0 ml > 240 Simulated Gastric Acid Fluid Mix 50/50 Solution 59 Simulated Gastric Acid Fluid/ 100.0 > 240 Xylazine HCl Mix 50/50 Solution Warning: do not use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 21.5 minutes Thiotepa 10.0 mg/ml 13.6 minutes Tested Non-drugs Solution Concentration(mg/ml) Minimum Breakthrough Detection Time(Min) 01 Simulated Gastric Acid Fluid - > 240

Source page: https://510kreport.com/device/K252244
Methodology: https://510kreport.com/methodology