The following data is part of a premarket notification filed by Cardinal Health-medical Products And Services with the FDA for Sterile Polyisoprene Powder-free Blue Surgical Gloves With Neu-thera Emollient Coating.
| Device ID | K111868 |
| 510k Number | K111868 |
| Device Name: | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Tatyana Bogdan CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. 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 | 2011-07-01 |
| Decision Date | 2011-09-21 |
| Summary: | summary |