# K113440: High Five

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: May 23, 2012 after 184 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 K093696 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093696: SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803, Central Medicare Sdn Bhd (2010) Summary page 1.
- K103734: Powder Free Nitrile Examination Gloves White Colored Non-Sterile, Central Medicare Sdn Bhd (2011) Summary page 1.

## Indications for use
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K113440
Methodology: https://510kreport.com/methodology