# K253824: Powder Free Nitrile Examination Gloves Non-Sterile Black

- Pathway: 510(k) (Traditional)
- Applicant: Kanglongda Vietnam Protection Technology Company Limited
- Decided: Jun 18, 2026 after 199 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: 3 generations back to K171422 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232008: Disposable Medical Examination Nitrile Gloves, Raxwell Industrial, LLC (2023) Summary page 5.

## Indications for use
Powder Free Nitrile Examination Gloves Non-Sterile Black is a disposable device intended for medical purposes that is worn on a examiner's hand to prevent the contamination between patient and examiner

Source page: https://510kreport.com/device/K253824
Methodology: https://510kreport.com/methodology