# K231973: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ineo Tech Sdn Bhd
- Decided: Sep 29, 2023 after 88 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: 1 generation back to K192933 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192933: Polyisoprene Powder Free, Black Colour Surgical Gloves, Emerson & Co. Srl (2021) Summary page 4.

## Indications for use
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination

Source page: https://510kreport.com/device/K231973
Methodology: https://510kreport.com/methodology