Safetex Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Safetex Corp. makes
Safetex Corp. manufactures condoms and related accessories, including latex products like the Saxon Ultra Thin, Saxon Ribbed, and Saxon Wet Lube variants, as well as themed condoms such as the Gold Circle Coin, Embrace, and Rainbow designs. The company also produces modifications for condom shelf-life preservation.
These products are classified as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. Safetex Corp. is based in the United States.
Catalogue
Condoom Shelf Life -- Modifications Ref K922889
Regimes: 510(k) Registry: 510(k)Saxon Ultra Thin Ref K900360
Regimes: 510(k) Registry: 510(k)Saxon Ribbed Condoms Ref K902509
Regimes: 510(k) Registry: 510(k)Saxon Wet Lube Ref K900358
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Gold Circle Coin Ref K900357
Regimes: 510(k) Registry: 510(k)Embrace Ref K900359
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safetex Corp. have in the registry?
The registry currently lists 7 devices for Safetex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safetex Corp.'s devices?
Among its 7 most recently registered devices, Safetex Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Safetex Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Safetex Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Safetex Corp. in the registry?
The most recently registered devices listed for Safetex Corp. include CONDOOM SHELF LIFE -- MODIFICATIONS, SAXON ULTRA THIN, SAXON RIBBED CONDOMS and SAXON WET LUBE.