# K152937: EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

- Pathway: 510(k) (Traditional)
- Applicant: Eco Medi Glove Sdn. Bhd.
- Decided: Jun 23, 2016 after 262 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: 1 generation back to K070097 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070097: Powder Free Nitrile Examination Gloves, Peppermint Scented, Blue Color, Gx Corporation Sdn Bhd (2007) 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 hands or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K152937
Methodology: https://510kreport.com/methodology