# K161320: EMG Pink Nitrile Examination Glove Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Sep 1, 2016 after 113 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 K100603 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141590: Emg Blue Nitrile Medical Examination Glove Powder Free, Eco Medi Glove Sdn. Bhd. (2014) Summary page 5.

## Indications for use
A powder-free patient examination 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

Source page: https://510kreport.com/device/K161320
Methodology: https://510kreport.com/methodology