# K251716: Nitrile Powder-Free Exam Gloves 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: Aug 27, 2025 after 84 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.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212408: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid), Pt. Maja Agung Latexindo (2022) Summary page 6.

## Indications for use
The glove 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 Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. NO. Chemotherapy Drugs Minimum Breakthrough Detection Time 1 Carboplatin, 10 mg/ml >240 min. 2 Carmustine, 3.3 mg/ml 15.3 min. 3 Cisplatin, 1 mg/ml >240 min. 4 Cyclophosphamide, 20 mg/ml >240 min. 5 Cytarabine HCl, 100 mg/ml >240 min. 6 Dacarbazine, 10 mg/ml >240 min. 7 Daunorubicin HCl, 5 mg/ml >240 min. 8 Doxorubicin HCl, 2 mg/ml >240 min. 9 Etoposide, 20 mg/ml >240 min. 10 5-Fluorouracil, 50 mg/ml >240 min. 11 Gemcitabine HCl, 38 mg/ml >240 min. 12 Ifosfamide, 50 mg/ml >240 min. 13 Irinotecan HCl, 20 mg/ml >240 min. 14 Mechlorethamine HCl, 1 mg/ml >240 min. 15 Melphalan HCl, 5 mg/ml >240 min. 16 Methotrexate, 25 mg/ml >240 min. 17 Mitomycin-C, 0.5 mg/ml >240 min. 18 Mitoxantrone HCl, 2 mg/ml >240 min. 19 Pacilitaxel, 6 mg/ml >240 min. 20 Thiotepa, 10 mg/ml 28.2 min. NO. Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time 1 Fentanyl Citrate Injection,50mcg/ml >240 min. 2 Gastric Acid >240 min. 3 Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50 >240 min. *Please note that the following drugs have extremely low permeation times: Carmustine: 15.3 minutes, Thiotepa: 28.2 minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K251716
Methodology: https://510kreport.com/methodology