# K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
- Decided: Jun 18, 2015 after 127 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: 4 generations back to K993247 (1999). 4 ancestors in all.
13 later devices descend from it; 9 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131440: Powder Free Nitrile Patient Examination Gloves, Blue, Hebei Hongsen Plastics Technology Co, Ltd. (2013) Summary page 5.

## Most influential descendants
- 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
- K241970: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) (2024), 0 descendants of its own

## Indications for use
The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K150340
Methodology: https://510kreport.com/methodology