The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc. with the FDA for Gammex Non Latex Pi White Polyisoprene Surgical Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K190018 |
| 510k Number | K190018 |
| Device Name: | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | Ansell Healthcare Products, LLC. 2301 Robb Drive Reno, NV 89523 |
| Contact | Don Cronk |
| Correspondent | Don Cronk Ansell Healthcare Products, LLC. 2301 Robb Drive Reno, NV 89523 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-04 |
| Decision Date | 2019-05-23 |