The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Esteem Smt Polyisoprene Powder-free Surgical Sterile Gloves.
| Device ID | K093300 |
| 510k Number | K093300 |
| Device Name: | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-21 |
| Decision Date | 2009-10-30 |
| Summary: | summary |