# K171047: Sterile Polyisoprene Powder Free Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Jun 22, 2017 after 76 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: 2 generations back to K071746 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151694: Gammex PI Hybrid Surgical Gloves, Ansell Healthcare Products, LLC (2016) Summary page 4.

## Most influential descendants
- K230304: Polyisoprene Surgical Gloves (2023), 0 descendants of its own
- K203483: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (2021), 0 descendants of its own

## Indications for use
This surgeon's glove is a 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/K171047
Methodology: https://510kreport.com/methodology