# K232008: Disposable Medical Examination Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Raxwell Industrial, LLC
- Decided: Aug 8, 2023 after 33 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.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213121: Disposable Nitrile Examination Glove, Jiangsu Cureguard Glove Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) (2024), 1 descendant of its own
- K253824: Powder Free Nitrile Examination Gloves Non-Sterile Black (2026), 0 descendants of its own
- K260806: Nitrile Disposable Examination Gloves (2026), 0 descendants of its own

## Indications for use
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K232008
Methodology: https://510kreport.com/methodology