The following data is part of a premarket notification filed by Cardinal Health with the FDA for Latex Powder-free Examination Gloves With Coating.
| Device ID | K033789 |
| 510k Number | K033789 |
| Device Name: | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, IL 60085 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2004-05-07 |
| Summary: | summary |