The following data is part of a premarket notification filed by Cardinal Health with the FDA for Esteem Blue Polyisoprene Surgical Gloves With Coating (containing Chitosan, Provitamin B, Gluconolactone And Glycerol).
| Device ID | K042574 |
| 510k Number | K042574 |
| Device Name: | ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) |
| Classification | Surgeon's Gloves |
| Applicant | Cardinal Health 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2004-12-08 |
| Summary: | summary |