# K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Oct 7, 2014 after 112 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.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110921: Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs, Cardinal Health, Inc. (2011) Summary page 6.

## Most influential descendants
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (2015), 3 descendants of its own
- K181066: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (2018), 1 descendant of its own
- K233560: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (2024), 0 descendants of its own
- K193121: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (2020), 0 descendants of its own
- K161944: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (2016), 0 descendants of its own

## Indications for use
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs Chemotherapy Drug and concentration Minimum Breakthrough detection time in Minutes,0.01pg/cm?*/minute )Carmustine (BCNU) (3.3mg/ml) 1.3 minutes 2)Cyclophosphamide (20mg/ml) > 240 minutes 3)Cytarabine (100mg/ml) > 240 minutes 4)Doxorubicin Hydrochloride (2 mg/ml) > 240 minutes S)Etoposide (20mg/ml) > 240 minutes 6)Fluorouracil (50mg/ml) > 240 minutes 7)Methorexate (25mg/ml) > 240 minutes 8) Paclitaxel (6mg/ml) > 240 minutes 9) Thiotepa (10mg/ml) ' 67.8 minutes The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time : Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)

Source page: https://510kreport.com/device/K141623
Methodology: https://510kreport.com/methodology