# K051562: Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove -  Aloe Vera Coated  Green Colour

- Pathway: 510(k) (Traditional)
- Applicant: Terang Nusa Sdn Bhd
- Decided: Oct 20, 2005 after 129 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: 2 generations back to K032942 (2003). 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)
- K040503: Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour, Wrp Asia Pacific Sdn. Bhd. (2004). Our OCR of the scanned summary read K040303, FDA’s number for 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens (Hydrogel Vision Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloe Touch powder free polymer coated polyisoprene surgical gloves…”.

## 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.

Source page: https://510kreport.com/device/K051562
Methodology: https://510kreport.com/methodology