# K171615: Xingyu Nitrile Powder Free Patient Examination Gloves, White color

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Xingyu Gloves Co., Ltd.
- Decided: Jul 31, 2017 after 60 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: 3 generations back to K993247 (1999). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110248: Powder Free Nitrile Patient Examination Gloves, White Color, Jiangsu Dongling Plastic & Rubber Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K222713: White Nitrile Powder Free Patient Examination Glove, Non Sterile (2022), 0 descendants of its own
- K212802: powder free nitrile examination glove - white, non-sterile (2021), 0 descendants of its own
- K210775: White Nitrile Powder Free Patient Examination Glove, Non Sterile (2021), 0 descendants of its own

## Indications for use
Xingyu Powder Free Nitrile Patient Examination Gloves, White 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 the patient and examiner

Source page: https://510kreport.com/device/K171615
Methodology: https://510kreport.com/methodology