# K140989: Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
- Decided: Dec 22, 2014 after 249 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: 3 generations back to K013302 (2001). 3 ancestors in all.
2 later devices descend 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)
- K122557: Motex Powder-Free Nitrile Surgical Gloves, Shanghai Motex Healthcare Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K170515: Sterile Nitrile Surgical Gloves, Powder-free (2017), 1 descendant of its own
- K222350: Sterile Nitrile Surgical Gloves Powder Free (2023), 0 descendants of its own

## Indications for use
The powder free nitrile surgical glove, white color (Brand Name: Titanfine), 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/K140989
Methodology: https://510kreport.com/methodology