The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Gammex Pi Hybrid Surgical Gloves.
| Device ID | K151694 |
| 510k Number | K151694 |
| Device Name: | Gammex PI Hybrid Surgical Gloves |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Contact | Vasudev Dobariya |
| Correspondent | Vasudev Dobariya ANSELL HEALTHCARE PRODUCTS, LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-23 |
| Decision Date | 2016-03-09 |
| Summary: | summary |