# K023139: Romed Latex Surgical Gloves, Powdered, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Van Oostveen Medical B.V.
- Decided: Oct 22, 2003 after 397 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 K021065 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014278: Latex Surgeons Glove (Powdered), Brightway Gloves Pvt., Ltd. (2002)
- K021065: Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/GM Protein Claim, Primus Gloves Private, Ltd. (2002)

## Indications for use
The ROMED surgeon sterile powdered gloves is a single use disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K023139
Methodology: https://510kreport.com/methodology