The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Derma Prene Ultra Powder-free Polychloroprene Synthetic Surgical Gloves (chemotherapy Use).
| Device ID | K043508 |
| 510k Number | K043508 |
| Device Name: | DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Contact | Lon D Mcilvain |
| Correspondent | Lon D Mcilvain ANSELL HEALTHCARE PRODUCTS LLC 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-01-19 |
| Summary: | summary |