# K012819: Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9

- Pathway: 510(k) (Abbreviated)
- Applicant: Semperit Technische Produkte Gesellshaft
- Decided: Nov 16, 2001 after 85 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.
No later device cites it as a predicate yet.
0 of 2 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.

## 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/K012819
Methodology: https://510kreport.com/methodology