# K233405: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Dec 28, 2023 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: 5 generations back to K042805 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs, Eco Medi Glove Sdn. Bhd. (2017) Summary page 7.

## Indications for use
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are 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 Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim Chemotherapy Drug and Fentanyl Test Claim Concentration Minimum Breakthrough detection time in Minutes, ug/cm2/minute 1) Carmustine (3.3mg/ml or 3000ppm), 24.0 minutes 2) Cyclophosphamide (20mg/ml or 20,000ppm), >240 minutes 3) Cisplatin (1.0mg/ml or 1,000ppm), >240 minutes 4) Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), >240 minutes 5) Etoposide (20mg/ml or 20,000ppm), >240 minutes 6) Flourouracil (50mg/ml or 50,000), >240 minutes 7) Methorexate (25mg/ml or 25,000ppm), >240 minutes 8) Paclitaxel (6mg/ml or 6,000ppm), >240 minutes 9) Thiotepa (10mg/ml or 10,000ppm), 56.9 minutes 10) Ifosfamide (50mg/ml) >240 minutes 11) Mitoxantrone (2mg/ml) , >240 minutes 12) Vincristine Sulfate (1mg/ml) , >240 minutes 13) Carboplatin (10.0mg/ml), >240 minutes 14) Dacarbazine (DTIC) (10.0mg/ml) >240 minutes 15) Mitomicin C (0.5mg/ml) >240 minutes 16) 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 24.0 ug/cm2/minute. Thiotepa (10ug/ml) — Minimum Breakthrough detection time 56.9 ug/cm2/minute. WARNING: Not for use with Carmustine and ThioTepa

Source page: https://510kreport.com/device/K233405
Methodology: https://510kreport.com/methodology