The following data is part of a premarket notification filed by Arent Fox with the FDA for Powder Free Surgeon's Glove.
| Device ID | K944054 |
| 510k Number | K944054 |
| Device Name: | POWDER FREE SURGEON'S GLOVE |
| Classification | Scissors For Cystoscope |
| Applicant | ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Product Code | KGD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1994-11-17 |