# K123116: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)

- Pathway: 510(k) (Traditional)
- Applicant: Worldmed Manufacturing Sdn. Bhd.
- Decided: Feb 11, 2013 after 131 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: 2 generations back to K100603 (2010). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112924: RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name, Riverstone Resources Sdn Bhd (2012) Summary page 1.
- K061553: Non-Sterile, Powder-Free Black Nitrile Examination Gloves, Yty Industry (Manjung) Sdn Bhd (2006) Summary page 1.

## Most influential descendants
- K161099: Powder Free Nitrile Examination Gloves, Black (2017), 0 descendants of its own
- K151528: Powder Free Nitrile (Black) Examination Gloves (2015), 0 descendants of its own

## Indications for use
Chlorinated Powder Free Nitrite Examination Gloves (Black Colour) is a single use device intended for medical purposes that Is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient

Source page: https://510kreport.com/device/K123116
Methodology: https://510kreport.com/methodology