The following data is part of a premarket notification filed by Lucenxia Prescience Ag with the FDA for Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove.
| Device ID | K162852 |
| 510k Number | K162852 |
| Device Name: | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove |
| Classification | Surgeon's Gloves |
| Applicant | Lucenxia Prescience AG Rathausstrasse 7 Baar, CH 6341 |
| Contact | Robert Hill |
| Correspondent | Robert Hill Lucenxia Prescience AG Rathausstrasse 7 Baar, 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 | 2016-10-11 |
| Decision Date | 2017-02-08 |