# K140988: Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
- Decided: Aug 12, 2014 after 117 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 K964474 (1997). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121897: Protexis Latex Basic Sterile Powder-Free Surgical Gloves, Cardinal Health, Inc. (2012) Summary page 4.

## Most influential descendants
- K171550: Sterile Latex Surgical Gloves, Powder Free (2018), 2 descendants of its own
- K211953: Disposable Sterilized Latex Surgical Gloves (2022), 1 descendant of its own
- K230832: Powdered Free Sterile Natural Rubber Latex Surgical Gloves (2023), 0 descendants of its own

## Indications for use
The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K140988
Methodology: https://510kreport.com/methodology