# K223895: Disposable Medical Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
- Decided: Mar 23, 2023 after 85 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 K171422 (2018). 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)
- K222498: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL), Humanwell Healthcare Group Medical Supplies Co., Ltd. (2022) Summary page 5.

## Indications for use
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K223895
Methodology: https://510kreport.com/methodology