The following data is part of a premarket notification filed by Lucenxia Prescience Ag with the FDA for Finessis Violet Element Polyisoprene Powderfree Sterile Surgical Gloves.
| Device ID | K131751 |
| 510k Number | K131751 |
| Device Name: | FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | LUCENXIA PRESCIENCE AG RATHAUSSTRASSE 7 Baar, Zug, CH 6341 |
| Contact | Robert Hill |
| Correspondent | Robert Hill LUCENXIA PRESCIENCE AG RATHAUSSTRASSE 7 Baar, Zug, CH 6341 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-14 |
| Decision Date | 2013-09-25 |