The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Nitrile Blue Powder-free Examination Glove.
| Device ID | K211390 |
| 510k Number | K211390 |
| Device Name: | Nitrile Blue Powder-free Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | William Cisneros |
| Correspondent | William Cisneros Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2021-08-28 |