# K013604: Modification to: Ultralon (R) Powder Free Latex Surgical Gloves

- Pathway: 510(k) (Special)
- Applicant: Ansell Healthcare Products, Inc.
- Decided: Nov 13, 2001 after 13 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 K973699 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973699: Ultralon Powder Free Latex Surgical Glove, Johnson & Johnson Medical, Inc. (1997) Summary page 1.

## Indications for use
Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K013604
Methodology: https://510kreport.com/methodology