# K983962: Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health,Medical Products and Services
- Decided: Jan 8, 1999 after 63 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K983312: Ultrafree Sterile Latex Powder-Free Surgical Gloves. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K983962
Methodology: https://510kreport.com/methodology