# K211457: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

- Pathway: 510(k) (Traditional)
- Applicant: Ammex Corporation
- Decided: Dec 18, 2021 after 221 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: 5 generations back to K993247 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150340: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue), Hebei Hongsen Plastics Technology Co, Ltd. (2015) Summary page 5.

## Most influential descendants
- K221143: Nitrile Exam Gloves (Blue, Black) (2022), 0 descendants of its own

## Indications for use
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211457
Methodology: https://510kreport.com/methodology