The following data is part of a premarket notification filed by Semperit Technische Produkte Gesellshaft with the FDA for Sempermed Surgeons' Gloves - Supreme.
| Device ID | K981096 |
| 510k Number | K981096 |
| Device Name: | SEMPERMED SURGEONS' GLOVES - SUPREME |
| Classification | Surgeon's Gloves |
| Applicant | SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT 22 MODECENTERSTRASSE Vienna, AT A-1031 |
| Contact | Richard Ehrenfeldner |
| Correspondent | Richard Ehrenfeldner SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT 22 MODECENTERSTRASSE Vienna, AT A-1031 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-25 |
| Decision Date | 1998-10-29 |
| Summary: | summary |