The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Dermasure Green Sterile Syntheticpolychloroprene Powder-free Surgical Glove Tested For Use.
| Device ID | K192988 |
| 510k Number | K192988 |
| Device Name: | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested For Use |
| 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 | 2019-10-25 |
| Decision Date | 2020-04-01 |