# K050765: Lano-E Powder-Free Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: N.S. Uni-Gloves Sdn. Bhd.
- Decided: Apr 8, 2005 after 15 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K111718: LANO-E (2012), 0 descendants of its own

## Indications for use
The Lano-E, Powder Free, Nitrie Examination Gloves isa disposable device intended forMedical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K050765
Methodology: https://510kreport.com/methodology