Boston, MA, US · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NUC | Lubricant, Personal | Class II | Obstetrics/Gynecology | 2 | 2025-08-08 |
| MOL | Condom, Synthetic | Class II | Obstetrics/Gynecology | 2 | 2025-04-08 |
| HIS | Condom | Class II | Obstetrics/Gynecology | 2 | 2021-09-03 |
| LZA | — | — | — | 1 | 2023-09-21 |
| ITX | — | — | — | 1 | 2022-06-07 |
| QRZ | External Condom For Anal Intercourse Or Vaginal Intercourse | Class II | Obstetrics/Gynecology | 1 | 2022-02-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-08 | K250142 | Water-based Lubricant | NUC | Class II | Obstetrics/Gynecology |
| 2025-08-08 | K243972 | Plain Water-based Lubricant | NUC | Class II | Obstetrics/Gynecology |
| 2025-04-08 | K243967 | ONE Nitrile Condom | MOL | Class II | Obstetrics/Gynecology |
| 2024-08-23 | K240896 | ONE Nitrile Condom | MOL | Class II | Obstetrics/Gynecology |
| 2023-09-21 | K223214 | Powder-Free Nitrile Examination Gloves | LZA | — | — |
| 2022-06-07 | K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | ITX | — | — |
| 2022-02-23 | DEN210034 | ONE Male Condom | QRZ | Class II | Obstetrics/Gynecology |
| 2021-09-03 | K203536 | Male Latex Condom | HIS | Class II | Obstetrics/Gynecology |
| 2020-08-20 | K193578 | Non-spermicidal Lubricated Male Latex Condom | HIS | Class II | Obstetrics/Gynecology |