# K190860: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color

- Pathway: 510(k) (Abbreviated)
- Applicant: Ever Growth (Vietnam) Co., Ltd.
- Decided: Dec 23, 2019 after 265 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: 1 generation back to K182176 (2019). 1 ancestor in all.
12 later devices descend from it; 12 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182176: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs, Pt. Medisafe Technologies (2019). Our reading of the summary gave K182156, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with…”.

## Most influential descendants
- K230847: Chemotherapy Gloves (2023), 0 descendants of its own
- K214056: Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K221271: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K220488: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (2022), 0 descendants of its own
- K220382: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple (2022), 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 | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min) 1 Carmustine (BCNU), 3.3 mg/ml 11.8 2 Thiotepa, 10.0 mg/ml 16.9 3 Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 4 Cisplatin, 1.0 mg/ml >240 5 Doxorubicin Hydrochloride, 2.0 mg/ml >240 6 Fluorouracil, 50.0 mg/ml >240 7 Dacarbazine (DTIC), 10.0 mg/ml >240 8 Etoposide (Toposar), 20.0 mg/ml >240 9 Paclitaxel (Taxol), 6.0 mg/ml >240 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 11.8 minutes Thiotepa 10.0 mg/ml 16.9 minutes Warning: Please do not use with Carmustine (BCNU) and Thiotepa 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 | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min) 1 Carmustine (BCNU), 3.3 mg/ml 31.6 2 Thiotepa, 10.0 mg/ml 72.5 3 Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 4 Cisplatin, 1.0 mg/ml >240 5 Doxorubicin Hydrochloride, 2.0 mg/ml >240 6 Fluorouracil, 50.0 mg/ml >240 7 Dacarbazine (DTIC), 10.0 mg/ml >240 8 Etoposide (Toposar), 20.0 mg/ml >240 9 Paclitaxel (Taxol), 6.0 mg/ml >240 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 31.6 minutes Thiotepa 10.0 mg/ml 72.5 minutes

Source page: https://510kreport.com/device/K190860
Methodology: https://510kreport.com/methodology