# K121529: Black Nitrile Powder-Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings
- Decided: Jul 12, 2012 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: 1 generation back to K060724 (2006). 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)
- K060724: Powder Free Nitrile Examination Glove (Black and Gray), Smart Glove Corp. Sdn Bhd (2006) Summary page 1.

## Most influential descendants
- K143131: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (2015), 1 descendant of its own
- K213934: Pro Guard Nitrile Powder Free Examination Glove (2022), 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/K121529
Methodology: https://510kreport.com/methodology