# K203483: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Hbm Health Protections, Inc.
- Decided: Feb 1, 2021 after 66 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 K050071 (2005). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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.
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 4.

## Indications for use
The Medispo Rubber/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/K203483
Methodology: https://510kreport.com/methodology