# K211540: Edma Synthetic Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Edma Group, LLC
- Decided: Aug 9, 2021 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: 5 generations back to K062764 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored), Careglove Global Sdn. Bhd. (2017) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211540
Methodology: https://510kreport.com/methodology