# K112924: RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: May 2, 2012 after 212 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: 1 generation back to K100603 (2010). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100603: RS Safe Blue Nitrile Medical Examination Gloves (Powder Free), Riverstone Resources Sdn Bhd (2010) Summary page 2.

## Most influential descendants
- K141579: Emg Black Nitrile Medical Examination Glove Powder Free (2014), 6 descendants of its own
- K200326: Powder Free Nitrile Examination Glove (Aqua Green) (2020), 4 descendants of its own
- K123116: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) (2013), 2 descendants of its own
- 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

## Indications for use
A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K112924
Methodology: https://510kreport.com/methodology