# K211953: Disposable Sterilized Latex Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Decided: May 25, 2022 after 336 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: 5 generations back to K964474 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171550: Sterile Latex Surgical Gloves, Powder Free, Sanrea Healthcare Products Pvt, Ltd. (2018) Summary page 4.

## Most influential descendants
- K230832: Powdered Free Sterile Natural Rubber Latex Surgical Gloves (2023), 0 descendants of its own

## Indications for use
The Disposable Sterilized Latex Surgical Glove is a device made of nature rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K211953
Methodology: https://510kreport.com/methodology