Semperit Investments Asia Pte, Ltd.
SingaporeFDA applicant, unverified
- Devices
- 3
What Semperit Investments Asia Pte, Ltd. makes
The company manufactures single-use surgical gloves, including sterile powder-free synthetic rubber gloves for surgeons and non-sterile powder-free nitrile gloves for patient examinations. The nitrile gloves are designed for low dermatitis potential and compatibility with chemotherapy drugs, while the surgical gloves are intended for sterile procedures.
These products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is based in the United States.
Catalogue
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs Ref K171378
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Semperit Investments Asia Pte, Ltd. have in the registry?
The registry currently lists 3 devices for Semperit Investments Asia Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Semperit Investments Asia Pte, Ltd.'s devices?
Among its 3 most recently registered devices, Semperit Investments Asia Pte, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Semperit Investments Asia Pte, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Semperit Investments Asia Pte, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Semperit Investments Asia Pte, Ltd. in the registry?
The most recently registered devices listed for Semperit Investments Asia Pte, Ltd. include Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs, Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves and Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs.