The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Derma Prene Pi Or Isotouch Green Sterile Powder-free Synthetic Polyisoprene Surgical Gloves.
| Device ID | K071746 |
| 510k Number | K071746 |
| Device Name: | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS, LLC 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Contact | Cynthia A Ingram |
| Correspondent | Cynthia A Ingram 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 | 2007-06-27 |
| Decision Date | 2007-12-13 |
| Summary: | summary |