# K222620: Sterilized Latex Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Colour-Way New Material Co., Ltd.
- Decided: Mar 23, 2023 after 205 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)
- K212596: Sterile Latex Surgical Gloves Powder Free, Amazing Rubber Products Pvt, Ltd. (2022) Summary page 4.

## Indications for use
The Sterilized Latex Surgical 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/K222620
Methodology: https://510kreport.com/methodology