# K121506: Utb Blue Powder Free Nitrile

- Pathway: 510(k) (Traditional)
- Applicant: Northstar Healthcare Holdings
- Decided: Jul 3, 2012 after 43 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 K091652 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091652: Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs, Hartalega Sdn Bhd (2009) Summary page 1.

## 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/K121506
Methodology: https://510kreport.com/methodology