Ultrawin Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 5
What Ultrawin Sdn Bhd makes
Ultrawin Sdn Bhd manufactures patient examination gloves, including powder-free latex options and polymer-coated varieties. These single-use, disposable products are available in various specifications, such as blue-colored latex gloves and the Ultrasafe line.
The company is based in the US and maintains a portfolio consisting of Class I medical devices. These products are listed within the FDA 510(k) regulatory registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Extra-Care Powder-Free Examination Glove Ref K983175
Regimes: 510(k) Registry: 510(k)Ultrasafe Ref K920059
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 Ultrawin Sdn Bhd have in the registry?
The registry currently lists 5 devices for Ultrawin Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultrawin Sdn Bhd's devices?
Among its 5 most recently registered devices, Ultrawin Sdn Bhd has devices listed in FDA 510(k) (5 devices).
What risk classes do Ultrawin Sdn Bhd's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Ultrawin Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ultrawin Sdn Bhd in the registry?
The most recently registered devices listed for Ultrawin Sdn Bhd include NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, EXTRA-CARE POWDER-FREE EXAMINATION GLOVE, ULTRASAFE and EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED.