The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Regent Biogel Latex-free Surgeon's Glove.
| Device ID | K951908 |
| 510k Number | K951908 |
| Device Name: | REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | REGENT HOSPITAL PRODUCTS 1050 CONNECTICUT AVENUE, NW Washington, DC 20036 -5339 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski REGENT HOSPITAL PRODUCTS 1050 CONNECTICUT AVENUE, NW Washington, DC 20036 -5339 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-09-01 |