The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Pi Surgical Gloves.
| Device ID | K152428 |
| 510k Number | K152428 |
| Device Name: | SensiCare PI Surgical Gloves |
| Classification | Surgeon's Gloves |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-03-31 |
| Summary: | summary |