# K200326: Powder Free Nitrile Examination Glove (Aqua Green)

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: Apr 9, 2020 after 59 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 K100603 (2010). 3 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141579: Emg Black Nitrile Medical Examination Glove Powder Free, Eco Medi Glove Sdn. Bhd. (2014) Summary page 4.

## Most influential descendants
- K213775: Glovatex™ White Latex Gloves, Glovanil™  Blue Nitrile Gloves (2022), 0 descendants of its own
- K211808: Medcare Powder-Free Blue Nitrile Patient Examination Gloves (2022), 0 descendants of its own
- K210990: Non-sterile Powder Free Nitrile Examination Gloves (2021), 0 descendants of its own
- K212290: Examination gloves -Type C (Nitrile gloves) (2021), 0 descendants of its own

## Indications for use
The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

Source page: https://510kreport.com/device/K200326
Methodology: https://510kreport.com/methodology