The following data is part of a premarket notification filed by Cardinal Health 200, Inc. with the FDA for Cardinal Healthtm Sterile Latex Powder-free Orthopedic Surgical Gloves With Hydrogel Coating.
| Device ID | K151778 |
| 510k Number | K151778 |
| Device Name: | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves With Hydrogel Coating |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH 200, INC. 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Caroline Miceli |
| Correspondent | Caroline Miceli CARDINAL HEALTH 200, 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 | 2015-07-01 |
| Decision Date | 2016-03-24 |
| Summary: | summary |