The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Protexis Latex Basic Sterile Powder-free Surgical Gloves.
| Device ID | K121897 |
| 510k Number | K121897 |
| Device Name: | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Tatyana Bogdan CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-07-27 |
| Summary: | summary |