FDA device listing
BARE RIDER CONDOM,LIFESTYLES ASSORTED COLORS,LIFESTYLES EXTRA STRENGTH CONDOM,LIFESTYLES LUBRICATED LATEX…
FDA device listing 1272124477 · Suretex Prophylactics (India) Private Limited
Key facts
| Proprietary names | BARE RIDER CONDOM,LIFESTYLES ASSORTED COLORS,LIFESTYLES EXTRA STRENGTH CONDOM,LIFESTYLES LUBRICATED LATEX CONDOM,LIFESTYLES NATURAL FEELING LATEX CONDOM,LIFESTYLES RIBBED CONDOM,LIFESTYLES RIBBED PLEASURE,LIFESTYLES SNUGGER FIT,LIFESTYLES TOUGH,LIFESTYLES ULTRA RIBBED LATEX CONDOM,LIFESTYLES ULTRA SENSITIVE LATEX CONDOM,LIFESTYLES ULTRA THIN CONDOM,LS NYC CONDOMS BLUE,MOMENTOS,ROUGH RIDER… |
|---|---|
| Owner/operator | Suretex Prophylactics (India) Private Limited |
| Owner/operator number | 9029871 |
| Premarket submissions | K941258 |
| Product codes | HIS |
| Device names | HIS - Condom |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.5300 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Suretex Prophylactics (India) Private Limited |
| Establishment registrations | 9613932 |
| FEI numbers | 3001687671 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database