# K100603: RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: Jul 16, 2010 after 135 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class I patient Examination gloves, Powder Free, LZA: named in the summary without a submission number

## Most influential descendants
- K112924: RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name (2012), 10 descendants of its own
- K141579: Emg Black Nitrile Medical Examination Glove Powder Free (2014), 6 descendants of its own
- K112928: RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name (2012), 6 descendants of its own
- K200326: Powder Free Nitrile Examination Glove (Aqua Green) (2020), 4 descendants of its own
- K141590: Emg Blue Nitrile Medical Examination Glove Powder Free (2014), 3 descendants of its own

## Recalls of this device
- Jan 22, 2016 · Class II · Z-1212-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1223-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1209-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1224-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1219-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1227-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1218-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1221-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1210-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1226-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1229-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1220-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1228-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1211-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1215-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1222-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1203-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1214-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1206-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1208-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1213-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1225-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1216-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1217-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

## 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/K100603
Methodology: https://510kreport.com/methodology