# K973699: Ultralon Powder Free Latex Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Dec 16, 1997 after 78 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NEUTRALON Brown Latex Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K013604: Modification to: Ultralon (R) Powder Free Latex Surgical Gloves (2001), 0 descendants of its own

## Indications for use
ULTRALON* Powder Free Latex Surgical Gloves are intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.

Source page: https://510kreport.com/device/K973699
Methodology: https://510kreport.com/methodology