# K243792: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

- Pathway: 510(k) (Traditional)
- Applicant: Basic Medical Technology, Inc.
- Decided: Feb 18, 2025 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: 3 generations back to K183287 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230779: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Shanxi Hongjin Plastic Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05. Chemotherapy Drugs Minimum Breakthrough Detection Time Carmustine (3.3mg/ml) 14.2 min Cisplatin (1mg/ml) >240 min Cyclophosphamide (20mg/ml) >240 min Dacarbazine (10.0 mg/ml) >240 min Doxorubicin HCI (2 mg/ml) >240 min Etoposide (20mg/ml) >240 min Fluorouracil (50mg/ml) >240 min Paclitaxel (6mg/ml) >240 min Thiotepa (10mg/ml) 14.7 min Fentanyl Concentration Minimum Breakthrough Detection Time Fentanyl Citrate Injection, 100mcg/2ml >240 min *Please note that the following drugs have extremely low permeation times: Carmustine: 14.2 minutes, Thiotepa:14.7 minutes Warning: Do not use with Carmustine and Thiotepa. Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (White) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05. Chem Drug Concentration Minimum Breakthrough Detection Time Carmustine (3.3mg/ml) 16.7 min Cisplatin (1mg/ml) >240 min Cyclophosphamide (20mg/ml) >240 min Dacarbazine (10.0 mg/ml) >240 min Doxorubicin HCI (2 mg/ml) >240 min Etoposide (20mg/ml) >240 min Fluorouracil (50mg/ml) >240 min Paclitaxel (6mg/ml) >240 min Thiotepa (10mg/ml) 16.2 min Fentanyl Concentration Minimum Breakthrough Detection Time Fentanyl Citrate Injection, 100mcg/2ml >240 min *Please note that the following drugs have extremely low permeation times: Carmustine: 16.7 minutes, Thiotepa:16.2 minutes Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K243792
Methodology: https://510kreport.com/methodology