# K232764: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Feb 7, 2024 after 152 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 K022765 (2002). 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)
- K103249: Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim, Cardinal Health, Inc. (2010) Summary page 7.

## Indications for use
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. It is for over-the- counter use. In addition, these gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Drug Concentration — Minimum Breakthrough detection time in Minutes Carmustine (3.3mg/ml or 3000ppm) — 15.4 minutes Cyclophosphamide (20mg/ml or 20,000ppm) — >240 minutes Cytarabine (100mg/ml) — >240 minutes Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm) — >240 minutes Etoposide (20mg/ml or 20,000ppm) — >240 minutes Flourouracil (50mg/ml or 50,000) — >240 minutes Methorexate (25mg/ml or 25,000ppm) — >240 minutes Paclitaxel (6mg/ml or 6,000ppm) — >240 minutes Thiotepa (10mg/ml or 10,000ppm) — 56.2 minutes Fentanyl Citrate Injection (100mg/2ml) — >240 minutes The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. - Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 15.4 minutes. - Thiotepa (10ug/ml) – Minimum Breakthrough detection time 56.2 minutes. WARNING: Not for use with Carmustine and ThioTepa

Source page: https://510kreport.com/device/K232764
Methodology: https://510kreport.com/methodology