The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Cardinal Health Sterile Polyisoprene Powder-free Orthopedic Surgical Gloves With Hydrogel Coating.
| Device ID | K160875 |
| 510k Number | K160875 |
| Device Name: | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves With Hydrogel Coating |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH, INC. 1500 WAUKEGAN RD Waukegan, IL 60085 |
| Contact | Megan Middaugh |
| Correspondent | Megan Middaugh CARDINAL HEALTH, INC. 1500 WAUKEGAN RD Waukegan, 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 | 2016-03-30 |
| Decision Date | 2016-07-11 |
| Summary: | summary |