Enzymic Technologies Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Enzymic Technologies Sdn Bhd makes
Enzymic Technologies Sdn Bhd manufactures latex examination gloves, including powder-free and powdered, nonsterile versions designed for medical and clinical use.
These products fall under FDA Class I regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Latex Examination Gloves-Powder Free Ref K010356
Regimes: 510(k) Registry: 510(k)Latex Examination Gloves-Powdered, Nonsterile Ref K010347
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enzymic Technologies Sdn Bhd have in the registry?
The registry currently lists 2 devices for Enzymic Technologies Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enzymic Technologies Sdn Bhd's devices?
Among its 2 most recently registered devices, Enzymic Technologies Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Enzymic Technologies Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Enzymic Technologies Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Enzymic Technologies Sdn Bhd in the registry?
The most recently registered devices listed for Enzymic Technologies Sdn Bhd include LATEX EXAMINATION GLOVES-POWDER FREE and LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE.