# K915086: Hpi Brown Nitrile Sensi-Grip Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hpi, Inc.
- Decided: Jun 17, 1992 after 218 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012166: Nitrile Powder-Free Medical Examination Glove (Brown) (2001), 2 descendants of its own
- K030075: Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured) (2003), 0 descendants of its own
- K022024: Nitrile Powder-Free Medical Examination Glove (Green) (2002), 0 descendants of its own
- K970135: Nitrile Gloves (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K915086
Methodology: https://510kreport.com/methodology