# K983982: Sensicare Synthetic Powder Free Surgical Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Maxxim Medical
- Decided: May 4, 1999 after 176 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 K933062 (1994). 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)
- K933062: B-D (R) Challenge Powder Free Synthetic Surg Gloves, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Indications for use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K983982
Methodology: https://510kreport.com/methodology