The following data is part of a premarket notification filed by Hpi, Inc. with the FDA for Hpi Sensi-shield Glove Kit.
| Device ID | K910383 |
| 510k Number | K910383 |
| Device Name: | HPI SENSI-SHIELD GLOVE KIT |
| Classification | Surgeon's Gloves |
| Applicant | HPI, INC. 64 MYRTLE ST. West Newton, MA 02165 |
| Contact | Imogene Tibbets |
| Correspondent | Imogene Tibbets HPI, INC. 64 MYRTLE ST. West Newton, MA 02165 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-03-20 |