# K143477: Nitrile Patient Examination gloves, Powderfree, Blue color

- Pathway: 510(k) (Traditional)
- Applicant: Primus Gloves Pvt Limited
- Decided: Apr 14, 2016 after 496 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 K062764 (2007). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves, Northstar Healthcare Holdings (2012) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The Nitrile Patient Examination gloves, Powderfree, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K143477
Methodology: https://510kreport.com/methodology