The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline Powder-free Nitrile Exam Glove Extended Cuff (tested For Use With Chemotherapy Dr).
| Device ID | K161473 |
| 510k Number | K161473 |
| Device Name: | Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested For Use With Chemotherapy Dr) |
| Classification | Polymer Patient Examination Glove |
| Applicant | MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason 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 | 2016-05-27 |
| Decision Date | 2016-10-19 |
| Summary: | summary |