# K171550: Sterile Latex Surgical Gloves, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Sanrea Healthcare Products Pvt, Ltd.
- Decided: Jul 13, 2018 after 413 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 K964474 (1997). 4 ancestors in all.
2 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)
- K140988: Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine), Hebei Hongsen Plastics Technology Co, Ltd. (2014) Summary page 5.

## Most influential descendants
- 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 Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber, intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K171550
Methodology: https://510kreport.com/methodology