# K212182: Iconic Nitrile Glove

- Pathway: 510(k) (Traditional)
- Applicant: Iconic Medicare Sdn Bhd
- Decided: Dec 11, 2021 after 151 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 K022904 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210755: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue), Meditech Gloves Sdn Bhd (2021) Summary page 4.

## Indications for use
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212182
Methodology: https://510kreport.com/methodology