The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Powder-free Nitrile Examination Glove With Aloe.
| Device ID | K081594 |
| 510k Number | K081594 |
| Device Name: | MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE |
| 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 | 2008-06-06 |
| Decision Date | 2008-10-17 |