# K150609: Annuy Latex Surgeon's Gloves (Powdered and Powder Free)

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Anyu Latex Products Co., Ltd.
- Decided: Nov 16, 2015 after 251 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: 3 generations back to K050071 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130301: Latex Surgeon's Gloves (Powdered and Powder Free), Elimedical Devices (Fujian), Inc. (2013) Summary page 4.

## Indications for use
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K150609
Methodology: https://510kreport.com/methodology