# K093696: SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Feb 12, 2010 after 74 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103734: Powder Free Nitrile Examination Gloves White Colored Non-Sterile (2011), 2 descendants of its own
- K113440: High Five (2012), 0 descendants of its own
- K120184: Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White Colored (2012), 0 descendants of its own

## Indications for use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K093696
Methodology: https://510kreport.com/methodology