Chem-Specialties Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Chem-Specialties Sdn Bhd makes
Chem-Specialties Sdn Bhd manufactures latex patient examination gloves, designed for single-use medical procedures requiring barrier protection.
These gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K892177
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chem-Specialties Sdn Bhd have in the registry?
The registry currently lists 1 device for Chem-Specialties Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chem-Specialties Sdn Bhd's devices?
Among its 1 most recently registered device, Chem-Specialties Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Chem-Specialties Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Chem-Specialties Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Chem-Specialties Sdn Bhd in the registry?
The most recently registered devices listed for Chem-Specialties Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).