The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Nitrile Exam Gloves W/aloe -green.
| Device ID | K090568 |
| 510k Number | K090568 |
| Device Name: | MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN |
| Classification | Polymer Patient Examination Glove |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-10-02 |