# K171616: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Xingyu Gloves Co., Ltd.
- Decided: Jul 20, 2017 after 49 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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
- K212578: Nitrile disposable examination gloves (2021), 0 descendants of its own

## Indications for use
Xingyu 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/K171616
Methodology: https://510kreport.com/methodology