# K040503: Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour

- Pathway: 510(k) (Special)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Mar 16, 2004 after 18 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
Longest line of descent: 1 generation back to K032942 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032942: Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile, Wrp Asia Pacific Sdn. Bhd. (2003) Summary page 1.

## Most influential descendants
- K051562: Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove -  Aloe Vera Coated  Green Colour (2005), 0 descendants of its own

## Recalls of this device
- Oct 23, 2017 · Class II · Z-0162-2018: Possible open seal on top portion of the package. Could cause breach of sterility.

## Indications for use
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K040503
Methodology: https://510kreport.com/methodology