The following data is part of a premarket notification filed by Cardinal Health with the FDA for Esteem Stretchy Vinyl Glove With Coating.
| Device ID | K052568 |
| 510k Number | K052568 |
| Device Name: | ESTEEM STRETCHY VINYL GLOVE WITH COATING |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park, IL 60085 |
| Contact | Amy Hoyd |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2005-11-28 |
| Summary: | summary |