# K023236: Sensicare -C Synthetic Polyisoprene Powder-Free Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Nov 12, 2002 after 46 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 K002933 (2000). 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)
- K002933: Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves, Maxxim Medical (2000) Summary page 1.

## Indications for use
A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon’s hand to prevent contamination between patient and surgeon.

Source page: https://510kreport.com/device/K023236
Methodology: https://510kreport.com/methodology