# K020918: Elastyfree Synthetic Powder-Free Surgical Glove

- Pathway: 510(k) (Special)
- Applicant: Eci Medical Technologies, Inc.
- Decided: Apr 19, 2002 after 29 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
- K121335: G-Derm Powder-Free Synthetic Surgical Glove (2012), 0 descendants of its own

## Indications for use
A powder-free surgeon’s glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K020918
Methodology: https://510kreport.com/methodology