The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Neoprene Synthetic Polychloroprene Surgical Glove (tested For Use With Chemotherapy Drugs).
| Device ID | K192820 |
| 510k Number | K192820 |
| Device Name: | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested For Use With Chemotherapy Drugs) |
| Classification | Surgeon's Gloves |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-02-28 |