Reno, NV, US · 5 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LZA | — | — | — | 3 | 2022-03-10 |
| KGO | — | — | — | 2 | 2023-08-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-03 | Class II | Ongoing | Z-0097-2024 | NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 | — | Some surgical glove sterile pouches were not completely sealed. |
| 2023-08-03 | Class II | Ongoing | Z-0096-2024 | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 | — | Some surgical glove sterile pouches were not completely sealed. |
| 2022-02-19 | Class II | Ongoing | Z-0838-2022 | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2 | — | Transport company failed to stop at the border for required FDA inspection. |
| 2020-08-19 | Class II | Terminated | Z-0051-2021 | MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device in… | — | Examination gloves were shipped inadvertently, without to verify barrier integrity. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-08-23 | K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | KGO | — | — |
| 2023-05-26 | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | KGO | — | — |
| 2022-03-10 | K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | LZA | — | — |
| 2021-06-13 | K210401 | 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 Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | — | — |
| 2020-06-19 | K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | LZA | — | — |