The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Cardinal Health Sterile Neoprene Powder-free Surgical Gloves With Nitrile Coating And Tested For Use With Chemotherapy Drugs (yellow).
| Device ID | K153316 |
| 510k Number | K153316 |
| Device Name: | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves With Nitrile Coating And Tested For Use With Chemotherapy Drugs (Yellow) |
| Classification | Surgeon's Gloves |
| Applicant | Cardinal Health, Inc. 1500 Waukegan Road Waukegan, IL 60085 |
| Contact | Megan Middaugh |
| Correspondent | Megan Middaugh Cardinal Health, Inc. 1500 Waukegan Road 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 | 2015-11-17 |
| Decision Date | 2016-05-12 |
| Summary: | summary |