The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Microflex Nitrile Patient Examination Gloves With Aloe And Chamomile Blue Green Pink Colored Tested For.
| Device ID | K200671 |
| 510k Number | K200671 |
| Device Name: | Microflex Nitrile Patient Examination Gloves With Aloe And Chamomile Blue Green Pink Colored Tested For |
| 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 | 2020-03-13 |
| Decision Date | 2020-06-19 |