The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Powder-free Nitrile Examination Gloves (cool Blue).
| Device ID | K122696 |
| 510k Number | K122696 |
| Device Name: | POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-01-31 |
| Summary: | summary |