The following data is part of a premarket notification filed by Hpi, Inc. with the FDA for Hpi Brown Nitrile Sensi-grip Surgical Gloves.
| Device ID | K915086 |
| 510k Number | K915086 |
| Device Name: | HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | HPI, INC. 931 SECOND AVENUE S.E. Fayette, AL 35555 |
| Contact | Carol Essary |
| Correspondent | Carol Essary HPI, INC. 931 SECOND AVENUE S.E. Fayette, AL 35555 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1992-06-17 |