The following data is part of a premarket notification filed by Regent Hospital Products with the FDA for Rubber Latex Surgeons Gloves.
| Device ID | K910928 |
| 510k Number | K910928 |
| Device Name: | RUBBER LATEX SURGEONS GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski REGENT HOSPITAL PRODUCTS C/O ARENT-FOX-KINT-PLOTK-KAHN 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-06-13 |