The following data is part of a premarket notification filed by Medicine Industries, Inc with the FDA for Sensicare Sterile Power-free Polymer Coated Polyisoprene Sugical Glove, Coated With Aloe V.
| Device ID | K191915 |
| 510k Number | K191915 |
| Device Name: | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated With Aloe V |
| Classification | Surgeon's Gloves |
| Applicant | Medicine Industries, Inc Three Lake Drive Northfiled, IL 60093 |
| Contact | Jenneifer Mason |
| Correspondent | Jenneifer Mason Medicine Industries, Inc Three Lake Drive Northfiled, 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 | 2019-07-17 |
| Decision Date | 2020-03-06 |