# K161187: 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: Sep 9, 2016 after 135 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: 3 generations back to K042805 (2004). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 6.

## Most influential descendants
- K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (2018), 3 descendants of its own
- K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs (2017), 3 descendants of its own
- K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (2019), 2 descendants of its own
- K212408: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) (2022), 1 descendant of its own
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (2022), 1 descendant of its own

## Indications for use
A powder-free patient eaxmination glove 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 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 Drugs and Concentration Minimum Breakthrough Detection Time (Min), pg/cm*minute 1) Carmustine (BCNU)(3.3mg/ml) 1.3 minutes 2) Cyclophosphamide (20mg/ml) > 240 minutes 3) Cytarabine (100mg/ml) > 240 minutes 4) Doxorubicin Hydrochloride (2mg/ml) > 240 minutes 5) Etopside (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)-Minimum breakthrough detection time : 1.3 pg/cm*minute Thiotepa (10mg/ml) -Minimum breakthrough detection time : 67.8 pg/cm*minute

Source page: https://510kreport.com/device/K161187
Methodology: https://510kreport.com/methodology