# K220382: Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Bytech Medical Supplies Co., Ltd.
- Decided: Apr 21, 2022 after 70 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 K182176 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Ever Growth (Vietnam) Co., Ltd. (2019) 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 chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. 1. The following is the resistance to permeation by chemotherapy drugs for the blue gloves. Chemotherapy Drug — Concentration — Breakthrough Detection Time in Minutes Carmustine — 3.3 mg/ml — 26.6 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 — 58.8 Minutes Vincristine Sulfate — 1.0 mg/ml — > 240 Minutes Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 26.6 Minutes ThioTepa 10.0 mg/ml 58.8 Minutes Warning: Please do not use with Carmustine and ThioTepa. 2. The following is the resistance to permeation by chemotherapy drugs for the black gloves. Chemotherapy Drug — Concentration — Breakthrough Detection Time in Minutes Carmustine — 3.3 mg/ml — 27.3 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 — 77.8 Minutes Vincristine Sulfate — 1.0 mg/ml — > 240 Minutes Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 27.3 Minutes ThioTepa 10.0 mg/ml 77.8 Minutes Warning: Please do not use with Carmustine and ThioTepa. 3. The following is the resistance to permeation by chemotherapy drugs for the purple gloves. Chemotherapy Drug — Concentration — Breakthrough Detection Time in Minutes Carmustine — 3.3 mg/ml — 23.5 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 — 56.1 Minutes Vincristine Sulfate — 1.0 mg/ml — > 240 Minutes Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 23.5 Minutes ThioTepa 10.0 mg/ml 56.1 Minutes Warning: Please do not use with Carmustine and ThioTepa.

Source page: https://510kreport.com/device/K220382
Methodology: https://510kreport.com/methodology