Nitritex (M) Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 3
What Nitritex (M) Sdn. Bhd. makes
Nitritex (M) Sdn. Bhd. manufactures powder-free examination gloves, including nitrile and polychloroprene variants designed for chemical resistance. Their product line also includes a protective barrier solution labeled as BIOCLEAN CHEMO SHIELD, intended for use in healthcare settings.
These devices are classified as Class I under regulatory frameworks and are listed via FDA 510(k) clearance. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bioclean Chemo Shield Ref K081970
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nitritex (M) Sdn. Bhd. have in the registry?
The registry currently lists 3 devices for Nitritex (M) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nitritex (M) Sdn. Bhd.'s devices?
Among its 3 most recently registered devices, Nitritex (M) Sdn. Bhd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Nitritex (M) Sdn. Bhd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nitritex (M) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Nitritex (M) Sdn. Bhd. in the registry?
The most recently registered devices listed for Nitritex (M) Sdn. Bhd. include BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES, BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES and BIOCLEAN CHEMO SHIELD.