# K213678: Powder Free Blue Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Lienteh Technology Sdn Bhd
- Decided: Mar 22, 2022 after 120 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: 2 generations back to K022548 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172930: mCare Powder-free Blue Nitrile Examination Gloves, Mercator Medical (Thailand), Ltd. (2018) Summary page 5.

## Indications for use
Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K213678
Methodology: https://510kreport.com/methodology