The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Nitrile Powder-free Examination Glove With Colloidal Oatmeal Usp (tested For Use With Chemotherapy Drugs).
| Device ID | K162982 |
| 510k Number | K162982 |
| Device Name: | Medline Nitrile Powder-Free Examination Glove With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs) |
| 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 | 2016-10-26 |
| Decision Date | 2017-02-27 |
| Summary: | summary |