Sumirubber Industries (Kedah) Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 3
What Sumirubber Industries (Kedah) Sdn. Bhd. makes
Sumirubber Industries (Kedah) Sdn. Bhd. manufactures nitrile examination gloves, including powdered and powder-free variants in 4 mil thickness. These products are designed for medical and clinical use, providing barrier protection during examinations and procedures.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. The manufacturer operates from the United States, adhering to regulatory requirements for non-sterile examination gloves.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Examination Gloves Ref K890393
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sumirubber Industries (Kedah) Sdn. Bhd. have in the registry?
The registry currently lists 3 devices for Sumirubber Industries (Kedah) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sumirubber Industries (Kedah) Sdn. Bhd.'s devices?
Among its 3 most recently registered devices, Sumirubber Industries (Kedah) Sdn. Bhd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sumirubber Industries (Kedah) Sdn. Bhd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sumirubber Industries (Kedah) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sumirubber Industries (Kedah) Sdn. Bhd. in the registry?
The most recently registered devices listed for Sumirubber Industries (Kedah) Sdn. Bhd. include NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED, EXAMINATION GLOVES and NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE.