# K013324: Hpi Sensi Grip Sterile Powdered Latex Surgical Glove,with Labeled Protein Content and Made From Allotex an Enzyme Treat

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Nov 29, 2001 after 55 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 K894828 (1990). 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)
- K894828: Hpi Ortho Surgeons' Glove, Tillotson Rubber Co., Inc. (1990) Summary page 1.

## Indications for use
The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K013324
Methodology: https://510kreport.com/methodology