# K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Jul 7, 2017 after 60 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: 4 generations back to K042805 (2004). 5 ancestors in all.
3 later devices descend from it; 2 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)
- K161187: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs, Eco Medi Glove Sdn. Bhd. (2016) Summary page 6.

## Most influential descendants
- K212408: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) (2022), 1 descendant of its own
- K251716: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (2025), 0 descendants of its own
- K233405: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim (2023), 0 descendants of its own

## Indications for use
A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and use for use with chemotherapy drugs. In addition these gloves were tested for use with chemotherapy drugs in accordance ASTM D6978-05 standards- Practice for assessment of Medical Glove to Permeation by chemotherapy drugs Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time(Min),pg/cm?/minutes 1) Carmustine (BCNU)(3.3 mg/ml) 24.0 Minutes 2)Cyclophoshamide (20 mg/ml) > 240 Minutes 3)Doxorubicin Hydrochloride (2mg/ml) > 240 Minutes 4)Etoposide (20mg/ml) > 240 Minutes 5)Fluorouracil (50mg/ml) > 240 Minutes 6)Methorexate (25mg/ml) > 240 Minutes 7)Paclitaxel (6mg/ml) > 240 Minutes 8)Thiotepa (10mg/ml) 56.9 Minutes 9)Carboplatin (10mg/ml) > 240 Minutes 10)Cisplatin (1 mg/ml) > 240 Minutes 1 1)Dacarabazine (1 mg/ml) > 240 Minutes 12)Ifosfamide (5 mg/ml) > 240 Minutes 13)Mitomycin (0.5mg/ml) > 240 Minutes 14)Mitoxantrone (2 mg/ml) > 240 Minutes 15)Vincristine Sulfate (1 mg/ml) > 240 Minutes The Maximum testing is 240 minutes. Please note that the following drugs have extremely low Permeation time, Carmustine (BCNU)(3.3 mg/ml) - Minimum breakthrough detection time : 24.0 minutes Thiotepa (10mg/ml) - Minimum breakthrough detection time : 56.9 minutes

Source page: https://510kreport.com/device/K171339
Methodology: https://510kreport.com/methodology