# K120890: Powder-Free Nitrie Examination Gloves, Orange

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Aug 17, 2012 after 147 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: 1 generation back to K090194 (2009). 1 ancestor in all.
2 later devices descend 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)
- K090194: Powder- Free Nitrile Examination Gloves, Black Color, Shen Wei (Usa), Inc. (2009) Summary page 1.

## Most influential descendants
- K200150: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) (2020), 1 descendant of its own
- K220825: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves (2022), 0 descendants of its own

## Indications for use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Source page: https://510kreport.com/device/K120890
Methodology: https://510kreport.com/methodology