# K013560: Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9

- Pathway: 510(k) (Abbreviated)
- Applicant: Semperit Technische Produkte Gesellshaft
- Decided: Jan 16, 2002 after 82 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: 1 generation back to K981096 (1998). 1 ancestor in all.
2 later devices descend 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)
- K981096: Sempermed Surgeons' Gloves - Supreme, Semperit Technische Produkte Gesellshaft (1998) Summary page 1.

## Most influential descendants
- K160781: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (2017), 1 descendant of its own
- 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
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

Source page: https://510kreport.com/device/K013560
Methodology: https://510kreport.com/methodology