# K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings
- Decided: Sep 10, 2012 after 69 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 K062764 (2007). 1 ancestor in all.
5 later devices descend from it; 2 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)
- K062764: Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Kossan Latex Industries (M)Sdn Bhd (2007) Summary page 1.

## Most influential descendants
- K143477: Nitrile Patient Examination gloves, Powderfree, Blue color (2016), 3 descendants of its own
- K223102: Tegamen Nitrile Examination Gloves (2023), 0 descendants of its own
- K220697: Nitrile Patient Examination Gloves, Powder Free (2022), 0 descendants of its own
- K163267: Nitrile Examination Glove (2017), 0 descendants of its own
- K123488: Linshi Nitrile Disposable Exam Gloves, Powder-Free (2013), 0 descendants of its own

## Indications for use
The examination glove is a 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/K121947
Methodology: https://510kreport.com/methodology