# K062764: Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored

- Pathway: 510(k) (Traditional)
- Applicant: Kossan Latex Industries (M)Sdn Bhd
- Decided: Feb 27, 2007 after 165 days
- Product code: LZC (Medical Glove, Specialty)
- 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
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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 no predicate by number.

## Most influential descendants
- K111772: Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile (2011), 11 descendants of its own
- K123469: Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile (2013), 10 descendants of its own
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (2015), 8 descendants of its own
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored) (2017), 5 descendants of its own
- K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves (2012), 5 descendants of its own

## Indications for use
A patient examination glove 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. This device is not intended to be used as a chemical barrier.

Source page: https://510kreport.com/device/K062764
Methodology: https://510kreport.com/methodology