The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Gammex Cut-resistant Glove Liner.
| Device ID | K160974 |
| 510k Number | K160974 |
| Device Name: | Gammex Cut-Resistant Glove Liner |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL HEALTHCARE PRODUCTS LLC 111 WOOD AVENUE SOUTH SUITE 210 Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Robert Mahler 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 | 2016-04-07 |
| Decision Date | 2016-10-28 |
| Summary: | summary |