# K131440: Powder Free Nitrile Patient Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
- Decided: Sep 25, 2013 after 128 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: 3 generations back to K993247 (1999). 3 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121992: Powder-Free Nitrile Patient Examination Gloves, Blue Color, Xinwei (Shandong) Plastic and Rubber Products Co., (2012) Summary page 1.

## Most influential descendants
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) (2015), 13 descendants of its own
- K211457: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) (2021), 1 descendant of its own
- K212497: Nitrile Examination Glove (Powder free, Blue) (2021), 1 descendant of its own
- K210898: Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) (2021), 1 descendant of its own
- K202356: Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) (2021), 1 descendant of its own

## Indications for use
The Titan powder free nitrile patient examination glove, 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. It has blue color and is sold as non sterile.

Source page: https://510kreport.com/device/K131440
Methodology: https://510kreport.com/methodology