The following data is part of a premarket notification filed by Cardinal Health with the FDA for Esteem Sterile Polyisoprene Surgical Gloves With Coating.
| Device ID | K031301 |
| 510k Number | K031301 |
| Device Name: | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING |
| Classification | Surgeon's Gloves |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, 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 | 2003-04-24 |
| Decision Date | 2003-10-15 |
| Summary: | summary |