# K111718: LANO-E

- Pathway: 510(k) (Traditional)
- Applicant: Ug Global Resources Sdn. Bhd.
- Decided: Jun 8, 2012 after 354 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 K050765 (2005). 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)
- K050765: Lano-E Powder-Free Nitrile Examination Glove, N.S. Uni-Gloves Sdn. Bhd. (2005) Summary page 1.

## Indications for use
Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue 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/K111718
Methodology: https://510kreport.com/methodology