# K171375: Gammex PI Breach Detect Powder Free Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Feb 6, 2018 after 272 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 K071746 (2007). 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)
- K071746: Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves, Ansell Healthcare Products, LLC (2007) Summary page 4.

## Indications for use
Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K171375
Methodology: https://510kreport.com/methodology