# K042534: Marina Medical Finger Protectors

- Pathway: 510(k) (Traditional)
- Applicant: Marina Medical Instruments, Inc.
- Decided: May 10, 2005 after 235 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: 2 generations back to K992539 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012199: Digicap, Humana USA, Inc. (2001) Summary page 1.

## Indications for use
This device is a protective finger guard accessory to the surgeon's glove. (a) intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. It is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. (b) Facilitate suture handling and placement.

Source page: https://510kreport.com/device/K042534
Methodology: https://510kreport.com/methodology