# K230304: Polyisoprene Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Puyang Linshi Medical Supplies Co., Ltd.
- Decided: Aug 9, 2023 after 187 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 K071746 (2007). 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)
- K171047: Sterile Polyisoprene Powder Free Surgical Gloves, Better Care Plastic Technology Co., Ltd. (2017) Summary page 4.

## Indications for use
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K230304
Methodology: https://510kreport.com/methodology