# K141590: Emg Blue Nitrile Medical Examination Glove Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Sep 3, 2014 after 82 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 K100603 (2010). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100603: RS Safe Blue Nitrile Medical Examination Gloves (Powder Free), Riverstone Resources Sdn Bhd (2010) Summary page 4.
- K112928: RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name, Riverstone Resources Sdn Bhd (2012) Summary page 6.

## Most influential descendants
- K180467: SBG Blue Nitrile Powder Free Medical Examination Glove (2018), 1 descendant of its own
- K203622: Medical Gloves (2021), 0 descendants of its own
- K161320: EMG Pink Nitrile Examination Glove Powder Free (2016), 0 descendants of its own

## Indications for use
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K141590
Methodology: https://510kreport.com/methodology