# K051563: Nuzone X2A Neoprene - Polyisoprene Powder Free Surgical Gloves Polymer and Aloe Coated

- Pathway: 510(k) (Special)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Jun 20, 2005 after 7 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Dec 18, 2006 · Not classified · Z-0365-2007: Some of the packages labeled as latex-free actually contain latex gloves.

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

Source page: https://510kreport.com/device/K051563
Methodology: https://510kreport.com/methodology