# K160781: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Semperit Investments Asia Pte, Ltd.
- Decided: May 2, 2017 after 406 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: 2 generations back to K981096 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013560: Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9, Semperit Technische Produkte Gesellshaft (2002) Summary page 4.

## Most influential descendants
- K250313: Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid (2025), 0 descendants of its own

## Indications for use
The Sterile Powder Free Synthetic Rubber Gloves is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K160781
Methodology: https://510kreport.com/methodology