# K250630: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Basic Medical Technology, Inc.
- Decided: May 22, 2025 after 80 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 K082457 (2008). 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)
- K231365: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves, Anhui Intco Medical Products Co., Ltd. (2024) Summary page 6.

## Indications for use
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. Chemotherapy Drugs Minimum Breakthrough Detection Time Carboplatin, 10 mg/ml >240 min. Carmustine, 3.3 mg/ml 11.6 min. Cisplatin, 1 mg/ml >240 min. Cyclophosphamide, 20 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine, 10 mg/ml >240 min. Daunorubicin HCL, 5 mg/ml >240 min. Doxorubicin HCI, 2 mg/ml >240 min. Etoposide, 20 mg/ml >240 min. 5-Fluorouracil, 50 mg/ml >240 min. Gemcitabine HCI, 38 mg/ml >240 min. Idarubicin HCI, 1 mg/ml >240 min. Ifosfamide, 50 mg/ml >240 min. Irinotecan HCI, 20 mg/ml >240 min. Mechlorethamine HCI, 1 mg/ml >240 min. Melphalan HCI, 5 mg/ml >240 min. Methotrexate, 25 mg/ml >240 min. Mitomycin-C, 0.5 mg/ml >240 min. Mitoxantrone HCL,, 2 mg/ml >240 min. Pacilitaxel, 6 mg/ml >240 min. Thiotepa, 10 mg/ml 25.3 min. Vincrinstine Sulfate,1 mg/ml >240 min. Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time Fentanyl Citrate Injection, S0mcg/ml >240 min. Simulated Gastric Acid >240 min. Fentanyl Citrate (50mcg/ml): Xylazine HCI(100mg/ml), 50:50 >240 min. *Please note that the following drugs have extremely low permeation times: Carmustine: 11.6 minutes, Thiotepa:25.3 minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K250630
Methodology: https://510kreport.com/methodology