Global Latex Products Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 2
What Global Latex Products Sdn Bhd makes
Global Latex Products Sdn Bhd manufactures patient examination gloves made from latex, designed for single-use medical and clinical procedures. These gloves are intended to provide barrier protection during direct patient contact in healthcare settings.
The company’s latex examination gloves are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for these products.
Catalogue
Patient Examination Gloves (Latex) Ref K892270
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Latex) Ref K891641
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Global Latex Products Sdn Bhd have in the registry?
The registry currently lists 2 devices for Global Latex Products Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Latex Products Sdn Bhd's devices?
Among its 2 most recently registered devices, Global Latex Products Sdn Bhd has devices listed in FDA 510(k) (2 devices).
What risk classes do Global Latex Products Sdn Bhd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Global Latex Products Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Global Latex Products Sdn Bhd in the registry?
The most recently registered devices listed for Global Latex Products Sdn Bhd include PATIENT EXAMINATION GLOVES (LATEX).