# K121992: Powder-Free Nitrile Patient Examination Gloves, Blue Color

- Pathway: 510(k) (Traditional)
- Applicant: Xinwei (Shandong) Plastic and Rubber Products Co.,
- Decided: Oct 16, 2012 after 102 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.
16 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082598: Powder Free Blue Patient Nitrile Examination Glove, Tangshan Zhonghong Pulin Group Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K131440: Powder Free Nitrile Patient Examination Gloves, Blue (2013), 15 descendants of its own
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (2015), 13 descendants of its own
- K211457: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) (2021), 1 descendant of its own
- K212497: Nitrile Examination Glove (Powder free, Blue) (2021), 1 descendant of its own
- K210898: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) (2021), 1 descendant of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21 CFR 880.6250)

Source page: https://510kreport.com/device/K121992
Methodology: https://510kreport.com/methodology