# K102119: Sur-G Glov and Maxitex

- Pathway: 510(k) (Special)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Aug 27, 2010 after 30 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The surgeon's gloves are sterile gloves to be worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.

Source page: https://510kreport.com/device/K102119
Methodology: https://510kreport.com/methodology