The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Cardinal Health Vinyl Powder-free Exam Gloves With Neu-thera Coating.
| Device ID | K160411 |
| 510k Number | K160411 |
| Device Name: | Cardinal Health Vinyl Powder-Free Exam Gloves With Neu-thera Coating |
| Classification | Vinyl Patient Examination Glove |
| 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-07-25 |
| Summary: | summary |