The following data is part of a premarket notification filed by Tillotson Rubber Co., Inc. with the FDA for Hpi Ortho Surgeons' Glove.
| Device ID | K894828 |
| 510k Number | K894828 |
| Device Name: | HPI ORTHO SURGEONS' GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | TILLOTSON RUBBER CO., INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Contact | Imogene Tibbetts |
| Correspondent | Imogene Tibbetts TILLOTSON RUBBER CO., INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1990-05-07 |