# K190736: Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Ever Growth (Vietnam) Co., Ltd.
- Decided: Dec 23, 2019 after 277 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: 6 generations back to K042805 (2004). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Central Medicare Sdn Bhd (2018) Summary page 5.

## Most influential descendants
- K234097: Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2024), 0 descendants of its own
- K212036: Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs (2021), 0 descendants of its own

## 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 chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. Test Chemotherapy Drug 01 Bleomycin Sulfate 02 Busulfan 03 Carboplatin 04 Carmustine (BCNU) 05 Chloroquine 06 Cisplatin 07 Cyclophosphamide 08 Cyclosporin A 09 Cytarabine 10 Dacarbazine (DTIC) 11 Daunorubicin 12 Docetaxel 13 Doxorubicin Hydrochloride 14 Epirubicin 15 Etoposide (Toposar) 16 Fludarabine 17 Fluorouracil 18 Gemcitabine 19 Idaribicin 20 Ifosfamide 21 Irinotecan 22 Mechlorethamine HCI 23 Melphalan 24 Methotrexate 25 Mitomycin C 26 Mitoxantrone 27 Oxaliplatin 28 Paclitaxel (Taxol) 29 Paraplatin 30 Retrovir 31 Rituximab 32 Thiotepa 33 Topotecan HCI 34 Trisonex 35 Velcade (Bortezomib) 36 Vincristine Concentration(mg/ml) 15.0 6.0 10.0 33 50.0 1.0 20.0 100.0 100.0 10.0 5.0 10.0 2.0 2.0 20.0 25.0 50.0 38.0 1.0 50.0 20.0 1.0 5.0 25.0 0.5 2.0 2.0 6.0 10.0 10.0 10.0 10.0 1.0 1.0 1.0 1.0 Minimum Breakthrough Detection Time ( Min) > 240 > 240 > 240 59.4 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 > 240 118.5 > 240 > 240 > 240 > 240

Source page: https://510kreport.com/device/K190736
Methodology: https://510kreport.com/methodology