# K071746: Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Dec 13, 2007 after 169 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K151694: Gammex PI Hybrid Surgical Gloves (2016), 5 descendants of its own
- K171047: Sterile Polyisoprene Powder Free Surgical Gloves (2017), 2 descendants of its own
- K182948: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (2019), 1 descendant of its own
- K231902: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (2023), 0 descendants of its own
- K230304: Polyisoprene Surgical Gloves (2023), 0 descendants of its own

## Indications for use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K071746
Methodology: https://510kreport.com/methodology