The following data is part of a premarket notification filed by Medline Industires, Inc. with the FDA for Medline Powder-free Light Blue Nitrile Exam Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K201390 |
| 510k Number | K201390 |
| Device Name: | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Medline Industires, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Adam Ostrower |
| Correspondent | Adam Ostrower Medline Industires, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-27 |
| Decision Date | 2020-09-18 |