The following data is part of a premarket notification filed by Medline with the FDA for Powder-free Blue Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K051378 |
| 510k Number | K051378 |
| Device Name: | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
| Classification | Polymer Patient Examination Glove |
| Applicant | MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason MEDLINE ONE MEDLINE PLACE Mundlelein, 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 | 2005-05-26 |
| Decision Date | 2005-08-03 |