# K230832: Powdered Free Sterile Natural Rubber Latex Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: The Egyptian Company For Medical & Electronic Industries
- Decided: Aug 16, 2023 after 142 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: 6 generations back to K964474 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211953: Disposable Sterilized Latex Surgical Gloves, Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. (2022) Summary page 4.

## Indications for use
The powdered free sterile natural rubber latex surgical gloves 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/K230832
Methodology: https://510kreport.com/methodology