# K223280: Disposible Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Holik Asia Group Co.,Ltd
- Decided: May 8, 2023 after 196 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: 5 generations back to K993247 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212924: Nitrile Examination Gloves, Shanxi Nacosa Medical Technology Co.,Ltd (2021) Summary page 5.

## Indications for use
The Disposable nitrile gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Source page: https://510kreport.com/device/K223280
Methodology: https://510kreport.com/methodology