Malaysian Healthcare Sdn. Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Malaysian Healthcare Sdn. Bhd makes
Malaysian Healthcare Sdn. Bhd produces patient examination gloves under the brand MAYCARE, designed for single-use medical examinations and procedures.
The company’s portfolio is regulated as Class I devices in the US, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Patient Examination Gloves (Maycare) Ref K915329
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Malaysian Healthcare Sdn. Bhd have in the registry?
The registry currently lists 1 device for Malaysian Healthcare Sdn. Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Malaysian Healthcare Sdn. Bhd's devices?
Among its 1 most recently registered device, Malaysian Healthcare Sdn. Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Malaysian Healthcare Sdn. Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Malaysian Healthcare Sdn. Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Malaysian Healthcare Sdn. Bhd in the registry?
The most recently registered devices listed for Malaysian Healthcare Sdn. Bhd include PATIENT EXAMINATION GLOVES (MAYCARE).