# K170515: Sterile Nitrile Surgical Gloves, Powder-free

- Pathway: 510(k) (Traditional)
- Applicant: Primus Gloves Pvt Limited
- Decided: Jun 9, 2017 after 108 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: 4 generations back to K013302 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140989: Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine), Hebei Hongsen Plastics Technology Co, Ltd. (2014) Summary page 5.

## Most influential descendants
- K222350: Sterile Nitrile Surgical Gloves Powder Free (2023), 0 descendants of its own

## Indications for use
The powder-free nitrile surgical gloves, is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.

Source page: https://510kreport.com/device/K170515
Methodology: https://510kreport.com/methodology