# K012199: Digicap

- Pathway: 510(k) (Traditional)
- Applicant: Humana USA, Inc.
- Decided: Dec 19, 2001 after 159 days
- Product code: GAB (Needle, Suturing, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K992539 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003063: Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip Protection, Gimbel Glove Co., LLC (2000) Summary page 1.
- K992539: Percuguard, Digit-Pro (2000) Summary page 1.

## Most influential descendants
- K042534: Marina Medical Finger Protectors (2005), 0 descendants of its own

## Indications for use
DigiCap™ is a protective finger guard accessory to the surgeon's glove. 1. Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ 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. 2. Facilitate suture handling and placement.

Source page: https://510kreport.com/device/K012199
Methodology: https://510kreport.com/methodology