The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Glide-on 3g Vinyl Examination Gloves.
| Device ID | K192985 |
| 510k Number | K192985 |
| Device Name: | Medline Glide-On 3G Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Stephanie Augsburg |
| Correspondent | Stephanie Augsburg Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-25 |
| Decision Date | 2020-01-21 |