Healthcare Gloves Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Healthcare Gloves Sdn Bhd makes
Healthcare Gloves Sdn Bhd manufactures patient examination gloves made from latex, designed for single-use in clinical settings to reduce cross-contamination during medical procedures.
The company’s latex examination gloves are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway in the United States.
Catalogue
Powder-Free Gloves Ref K943552
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Latex) Ref K891184
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthcare Gloves Sdn Bhd have in the registry?
The registry currently lists 2 devices for Healthcare Gloves Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthcare Gloves Sdn Bhd's devices?
Among its 2 most recently registered devices, Healthcare Gloves Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Healthcare Gloves Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Healthcare Gloves Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Healthcare Gloves Sdn Bhd in the registry?
The most recently registered devices listed for Healthcare Gloves Sdn Bhd include POWDER-FREE GLOVES and PATIENT EXAMINATION GLOVES (LATEX).