# K231446: Single-Use Latex Sterile Surgical Gloves (SG100)

- Pathway: 510(k) (Traditional)
- Applicant: Fitone Latex Products Co., Ltd. Guangdong
- Decided: Sep 22, 2023 after 127 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: 7 generations back to K050071 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212848: Sterile Latex Surgical Gloves Powder Free, Pentavest Holdings Sdn Bhd (2021) Summary page 5.

## Indications for use
The Single-Use Latex Sterile Surgical Gloves are 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/K231446
Methodology: https://510kreport.com/methodology