The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N.
| Device ID | K210401 |
| 510k Number | K210401 |
| Device Name: | Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ansell Healthcare Products LLC 2301 Robb Drive Reno, NV 89523 |
| Contact | Donald Cronk |
| Correspondent | Donald Cronk Ansell Healthcare Products LLC 2301 Robb Drive Reno, NV 89523 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-06-13 |