The following data is part of a premarket notification filed by Hpi, Inc. with the FDA for Hpi Powder Free Non-sterile Examination Gloves.
| Device ID | K901608 |
| 510k Number | K901608 |
| Device Name: | HPI POWDER FREE NON-STERILE EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | HPI, INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Contact | Deborah Denitto |
| Correspondent | Deborah Denitto HPI, INC. 825 BEACON ST. SUITE 11 Newton Centre, MA 02159 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1990-04-20 |