# K213016: ATM Glove

- Pathway: 510(k) (Traditional)
- Applicant: Phu Duc Huy Production Trading Services Corporation
- Decided: Dec 28, 2021 after 99 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 K022548 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192333: Blue Nitrile Examination Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 5.

## Most influential descendants
- K222813: Nitrile Examination Gloves (2023), 0 descendants of its own

## Indications for use
A Powder free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K213016
Methodology: https://510kreport.com/methodology