# K101351: Non-Sterile Powder- Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent

- Pathway: 510(k) (Traditional)
- Applicant: Ascend Eagle, Inc.
- Decided: Oct 15, 2010 after 154 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. The FDA summary names no predicate by number.

## Indications for use
These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) 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/K101351
Methodology: https://510kreport.com/methodology