The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Power-free Nitrile Examination Gloves - Blue (test For Use With Chemotherapy Drugs).
| Device ID | K192104 |
| 510k Number | K192104 |
| Device Name: | Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Claire Pigman |
| Correspondent | Claire Pigman Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | LZA |
| Subsequent Product Code | LYA |
| Subsequent Product Code | OPJ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-12-23 |