The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Protegrity Blue With Neu-thera Surgical Gloves.
| Device ID | K053272 |
| 510k Number | K053272 |
| Device Name: | CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | Cardinal Health 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Amy Hoyd |
| Correspondent | Amy Hoyd Cardinal Health 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-23 |
| Decision Date | 2006-01-05 |
| Summary: | summary |