The following data is part of a premarket notification filed by Ansell Healthcare Products, Inc. with the FDA for Derma Prene Isotouch Green Sterile Powder-free Polyisoprene Surgical Goves, Tested For U.
| Device ID | K111139 |
| 510k Number | K111139 |
| Device Name: | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS, INC. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Neil Burris |
| Correspondent | Neil Burris ANSELL HEALTHCARE PRODUCTS, INC. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2011-09-02 |
| Summary: | summary |