# K051094: Nuzone X2T Polychloroprene Synthetic Tan Surgical Glove - Powderfree

- Pathway: 510(k) (Special)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Jun 6, 2005 after 39 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
Longest line of descent: 1 generation back to K041436 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041436: Synthetic Surgical Glove-Powderfree Nuzone X2, Terang Nusa Sdn Bhd (2004) Summary page 1.

## Indications for use
This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Source page: https://510kreport.com/device/K051094
Methodology: https://510kreport.com/methodology