Sinetimed Latex Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Sinetimed Latex Sdn Bhd makes
Sinetimed Latex Sdn Bhd manufactures powder-free examination gloves, including latex (MAXIKLEEN-LATEX) and nitrile (NITRIKLEEN-NITRILE) variants, designed for medical and clinical use.
These products are classified as Class I devices and are listed under the FDA’s 510(k) pathway. The company is based in the US.
Catalogue
Maxikleen-Latex Examination Glove Powder Free Ref K983827
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sinetimed Latex Sdn Bhd have in the registry?
The registry currently lists 2 devices for Sinetimed Latex Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sinetimed Latex Sdn Bhd's devices?
Among its 2 most recently registered devices, Sinetimed Latex Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Sinetimed Latex Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sinetimed Latex Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sinetimed Latex Sdn Bhd in the registry?
The most recently registered devices listed for Sinetimed Latex Sdn Bhd include MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE and NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE.