The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Non-sterile Powder-free Polychloroprene Examination Glove (blue) Tested For Use With Chemotherapy Drugs.
| Device ID | K212148 |
| 510k Number | K212148 |
| Device Name: | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested For Use With Chemotherapy Drugs |
| 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 |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2022-03-10 |