# K041436: Synthetic Surgical Glove-Powderfree Nuzone X2

- Pathway: 510(k) (Traditional)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Aug 20, 2004 after 84 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) NUZONE Nitrile Surgical Gloves Powderfree: named in the summary without a submission number

## Most influential descendants
- K051094: Nuzone X2T Polychloroprene Synthetic Tan Surgical Glove - Powderfree (2005), 0 descendants of its own

## Indications for use
This surgical glove is a device made of a neoprene - polyisoprene synthetic material intended to be worn by operating room persomiel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K041436
Methodology: https://510kreport.com/methodology