Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231908
45 Micron Polyisoprene Condom · Suretex Limited · decided 2023-10-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SKYN | 08859798106997 | SURETEX LIMITED - BRANCH | MOL | 08859798106997 |
| SKYN | 08859798106034 | SURETEX LIMITED - BRANCH | MOL | 08859798106034 |
| SKYN | 08859798101435 | SURETEX LIMITED - BRANCH | MOL | 08859798101435 |
| SKYN | 08859798108533 | SURETEX LIMITED - BRANCH | MOL | 08859798108533 |
| SKYN | 08859798106980 | SURETEX LIMITED - BRANCH | MOL | 08859798106980 |
| SKYN | 08859798105891 | SURETEX LIMITED - BRANCH | MOL | 08859798105891 |
| SKYN | 08859798106966 | SURETEX LIMITED - BRANCH | MOL | 08859798106966 |
| SKYN | 08859798101473 | SURETEX LIMITED - BRANCH | MOL | 08859798101473 |
| SKYN | 08859798101466 | SURETEX LIMITED - BRANCH | MOL | 08859798101466 |
| SKYN | 08859798105877 | SURETEX LIMITED - BRANCH | MOL | 08859798105877 |
| SKYN | 08859798105846 | SURETEX LIMITED - BRANCH | MOL | 08859798105846 |
| SKYN | 08859798106041 | SURETEX LIMITED - BRANCH | MOL | 08859798106041 |
| SKYN | 08859798108540 | SURETEX LIMITED - BRANCH | MOL | 08859798108540 |
| SKYN | 08859798108632 | SURETEX LIMITED - BRANCH | MOL | 08859798108632 |
| SKYN | 08859798101480 | SURETEX LIMITED - BRANCH | MOL | 08859798101480 |
| SKYN | 08859798105884 | SURETEX LIMITED - BRANCH | MOL | 08859798105884 |
| SKYN | 08859798106027 | SURETEX LIMITED - BRANCH | MOL | 08859798106027 |
| SKYN | 08859798101459 | SURETEX LIMITED - BRANCH | MOL | 08859798101459 |
| SKYN | 08859798105778 | SURETEX LIMITED - BRANCH | MOL | 08859798105778 |
| SKYN | 08859798108441 | SURETEX LIMITED - BRANCH | MOL | 08859798108441 |
| SKYN | 08859798106973 | SURETEX LIMITED - BRANCH | MOL | 08859798106973 |
| SKYN | 08859798101442 | SURETEX LIMITED - BRANCH | MOL | 08859798101442 |
| SKYN | 08859798108953 | SURETEX LIMITED - BRANCH | MOL | 08859798108953 |