# K192933: Polyisoprene Powder Free, Black Colour Surgical Gloves

- Pathway: 510(k) (Special)
- Applicant: Emerson & Co. Srl
- Decided: Jan 13, 2021 after 454 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231973: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (2023), 0 descendants of its own

## Indications for use
The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K192933
Methodology: https://510kreport.com/methodology