Glatex Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Glatex Sdn Bhd makes
Glatex Sdn Bhd manufactures latex examination gloves designed for patient contact during clinical examinations. These gloves are intended for single-use medical procedures to maintain hygiene and reduce infection risk.
The company’s product portfolio is regulated as Class I medical devices under FDA 510(k) clearance requirements. The manufacturer is based in the US and lists its devices in the FDA’s 510(k) registry.
Catalogue
Nil Patient Examination Gloves (Latex) Ref K891834
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glatex Sdn Bhd have in the registry?
The registry currently lists 1 device for Glatex Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glatex Sdn Bhd's devices?
Among its 1 most recently registered device, Glatex Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Glatex Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Glatex Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Glatex Sdn Bhd in the registry?
The most recently registered devices listed for Glatex Sdn Bhd include NIL PATIENT EXAMINATION GLOVES (LATEX).