Shanghai Latex Factory
Country not established
- Devices
- 3
What Shanghai Latex Factory makes
The company manufactures single-use patient examination gloves made from latex and nitrile, including a line of protective examination gloves, as well as male condoms designed for contraception and barrier protection.
These products are regulated under FDA’s 510(k) pathway, with some classified as Class I and others as Class II. The devices are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K892138
Regimes: 510(k) Registry: 510(k)Profect Examination Gloves Ref K893280
Regimes: 510(k) Registry: 510(k)Tulip Condom Ref K050360
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shanghai Latex Factory have in the registry?
The registry currently lists 3 devices for Shanghai Latex Factory. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Latex Factory's devices?
Among its 3 most recently registered devices, Shanghai Latex Factory has devices listed in FDA 510(k) (3 devices).
What risk classes do Shanghai Latex Factory's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Shanghai Latex Factory's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Latex Factory in the registry?
The most recently registered devices listed for Shanghai Latex Factory include PATIENT EXAMINATION GLOVES (LATEX), PROFECT EXAMINATION GLOVES and TULIP CONDOM.