# K163035: DilaCheck Nitrile Powder Free Examination Glove, (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Elm Tree Medical, Inc.
- Decided: Jul 7, 2017 after 249 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A 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. Additionally, this device has the added component of a measuring tape to aid clinicians in the measurement of cervical dilation.

Source page: https://510kreport.com/device/K163035
Methodology: https://510kreport.com/methodology