# K981096: Sempermed Surgeons' Gloves - Supreme

- Pathway: 510(k) (Traditional)
- Applicant: Semperit Technische Produkte Gesellshaft
- Decided: Oct 29, 1998 after 218 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
No predicates in its family tree.
6 later devices descend from it; 4 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K013560: Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9 (2002), 2 descendants of its own
- 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
- K014112: Satari Latex Patient Examination Powdered Glove Single Side Polymer Coated, Non Sterile, 200 MG or Less of Total Water E (2002), 0 descendants of its own
- K014110: Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Polymer Coated Whit (2002), 0 descendants of its own

## Indications for use
This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K981096
Methodology: https://510kreport.com/methodology