# K894828: Hpi Ortho Surgeons' Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Rubber Co., Inc.
- Decided: May 7, 1990 after 280 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013324: Hpi Sensi Grip Sterile Powdered Latex Surgical Glove,with Labeled Protein Content and Made From Allotex an Enzyme Treat (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K894828
Methodology: https://510kreport.com/methodology