# K003063: Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip Protection

- Pathway: 510(k) (Traditional)
- Applicant: Gimbel Glove Co., LLC
- Decided: Nov 22, 2000 after 51 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012199: Digicap (2001), 1 descendant of its own
- K042534: Marina Medical Finger Protectors (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K003063
Methodology: https://510kreport.com/methodology