The following data is part of a premarket notification filed by Hpi, Inc. with the FDA for Hpi Tri-rads Vinyl Radiation Protection Gloves.
| Device ID | K905086 |
| 510k Number | K905086 |
| Device Name: | HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES |
| Classification | Radiographic Protective Glove |
| Applicant | HPI, INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Contact | Judith A Genzale |
| Correspondent | Judith A Genzale HPI, INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Product Code | IWP |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1990-12-03 |