The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Pi Evolution Surgical Glove (tested For Use With Chemotherapy Drugs).
| Device ID | K201829 |
| 510k Number | K201829 |
| Device Name: | SensiCare PI Evolution Surgical Glove (Tested For Use With Chemotherapy Drugs) |
| Classification | Surgeon's Gloves |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60030 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three Lakes Drive Northfield, IL 60030 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-09-09 |