# K181106: Powder Free Nitrile Patient Examination Gloves, Blue Color

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Dongxin Medical Technology Co., Ltd.
- Decided: Jan 16, 2019 after 265 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 K993247 (1999). 2 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120970: Nitrile Powder Free Patient Examination Gloves, Colored (Blue), Tangshan Zhonghong Pulin Plastic Co.,Ltd (2012) Summary page 4.

## Most influential descendants
- K203593: Patient Examination Gloves (2021), 12 descendants of its own
- K212924: Nitrile Examination Gloves (2021), 1 descendant of its own
- K223280: Disposible Nitrile Gloves (2023), 0 descendants of its own
- K223004: Disposable Nitrile Examination Gloves (2022), 0 descendants of its own
- K213848: Medical nitrile examination gloves (Model: JL001) (2022), 0 descendants of its own

## Indications for use
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K181106
Methodology: https://510kreport.com/methodology