The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Protexis Pi Blue With Neu-thera Surgical Glove.
| Device ID | K201592 |
| 510k Number | K201592 |
| Device Name: | Cardinal Health Protexis PI Blue With Neu-Thera Surgical Glove |
| Classification | Surgeon's Gloves |
| Applicant | Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | Padmini Sahoo |
| Correspondent | Padmini Sahoo Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2021-09-26 |